Bulgaplin

Package leaflet: Information for the user

Bulgaplin, 25 mg, hard capsules
Bulgaplin, 50 mg, hard capsules
Bulgaplin, 75 mg, hard capsules
Bulgaplin, 100 mg, hard capsules
Bulgaplin, 150 mg, hard capsules
Bulgaplin, 225 mg, hard capsules
Bulgaplin, 300 mg, hard capsules
Pregabalin
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Bulgaplin is and what it is used for

Bulgaplin belongs to a group of medicines used in the treatment of epilepsy, neuropathic pain,
and generalized anxiety disorders in adults.
Peripheral and central neuropathic pain
Bulgaplin is used to treat long-term pain caused by nerve damage.
Various diseases, such as diabetes or shingles, can cause peripheral neuropathic pain.
Pain sensations may be described as burning, shooting, stabbing, tingling, or numbness, as well as
sharp pain, cramps, aching, or pins and needles. Peripheral and central neuropathic pain may also
be associated with mood changes, sleep disturbances, and fatigue, which can affect the patient's
physical and social functioning and overall quality of life.
Epilepsy
Bulgaplin is used in the treatment of certain types of epilepsy (partial seizures, with or without
secondary generalization) in adults. Your doctor may prescribe Bulgaplin if previous treatment
has not fully controlled the condition. Bulgaplin should always be used as an add-on therapy to
current antiepileptic treatment. Bulgaplin should not be used as monotherapy, but always in
combination with other antiepileptic medicines.
Generalized anxiety disorder
Bulgaplin is used in the treatment of generalized anxiety disorder (GAD). GAD symptoms include
persistent, excessive anxiety and worry that are difficult to control. GAD may also cause motor
restlessness, nervousness or feeling keyed up, easy fatigability, difficulty concentrating or a
"blank mind," irritability, increased muscle tension, or sleep disturbances. These symptoms are
distinct from the stresses and strains of everyday life.

2. What you need to know before taking Bulgaplin
When not to take Bulgaplin

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

Warnings and precautions
Before starting Bulgaplin, discuss this with your doctor or pharmacist.

• Some patients taking pregabalin have experienced symptoms indicating an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as widespread skin rash. If any of these symptoms occur, contact your doctor immediately.

• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin. If you experience any symptoms of serious skin reactions listed in section 4, stop taking pregabalin and seek immediate medical help.

• Dizziness and drowsiness have been reported with pregabalin use: this may increase the risk of accidental injury (falls) in elderly patients. Therefore, exercise caution until you know how this medicine affects you.

• Pregabalin may cause blurred vision, loss of vision, or other visual disturbances, most of which are temporary. If you experience any changes in vision, inform your doctor immediately.

• In patients with diabetes, weight gain during pregabalin treatment may necessitate changes in antidiabetic therapy.

• Some side effects, such as drowsiness, may occur more frequently because patients with spinal cord injury may be taking other medicines, such as analgesics or muscle relaxants, which have similar side effects to pregabalin, and the effects may be intensified when such medicines are taken together.

• Cases of heart failure have been reported in some patients taking pregabalin; these were mainly elderly patients with cardiovascular disorders. Before taking this medicine, inform your doctor if you have a history of heart disease.

• Cases of renal failure have been reported in some patients taking pregabalin. If you notice a decrease in the frequency of urination while taking Bulgaplin, inform your doctor, as discontinuation of the medicine may resolve this symptom.

• A small number of patients taking antiepileptic medicines such as Bulgaplin have had thoughts of self-harm or suicide, or exhibited suicidal behavior. If you ever experience such thoughts or behaviors, contact your doctor immediately.

• If Bulgaplin is taken together with other medicines that may cause constipation (such as certain painkillers), gastrointestinal problems (e.g., constipation, bowel obstruction, or intestinal paralysis) may occur. Inform your doctor if you have constipation, especially if you are prone to it.

• Before starting this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines,
  or any illegal psychoactive substances; this may mean you have an increased risk of becoming dependent on Bulgaplin.

• Seizures have been reported during pregabalin treatment or shortly after discontinuation. If seizures occur, contact your doctor immediately.

• Cases of worsening brain function (encephalopathy) have been reported in some patients with other medical conditions who were taking pregabalin. Inform your doctor about all serious medical conditions you have had, including liver or kidney disease.

• Cases of breathing difficulties have been reported. If you have neurological disorders, breathing problems, kidney dysfunction, or are aged 65 years or older, your doctor may recommend a different dosing regimen. If you experience difficulty breathing or shallow breathing, contact your doctor.

Dependence
Some individuals may become dependent on Bulgaplin (a need to continue taking the medicine).
Withdrawal symptoms may occur after stopping Bulgaplin (see section 3 "How to take Bulgaplin" and "Stopping treatment with Bulgaplin"). If you are concerned that you may become dependent on Bulgaplin, you should discuss this with your doctor.
If, while taking Bulgaplin, you notice any of the following symptoms, this may indicate dependence:

• Needing to take the medicine for a longer period than prescribed by your doctor
• Feeling the need to take a higher dose than prescribed
• Taking the medicine for reasons other than those for which it was prescribed
• Repeated unsuccessful attempts to stop or control taking the medicine
• Feeling unwell after stopping the medicine and feeling better after restarting it

If you notice any of these symptoms, you should discuss them with your doctor to determine the best course of treatment, including when to stop taking this medicine and how to do so safely.

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

Bulgaplin with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Bulgaplin and certain medicines may interact with each other. When taken together with other central nervous system depressants (including opioids), Bulgaplin may intensify these effects and cause respiratory depression, coma, and death. The severity of dizziness, drowsiness, and reduced concentration may increase if Bulgaplin is taken together with medicines containing:

• oxycodone (a painkiller)
• lorazepam (a medicine used for anxiety)
• alcohol. Bulgaplin may be taken together with oral contraceptives.

Taking Bulgaplin with food, drink, and alcohol
Bulgaplin capsules may be taken with or without food.
Alcohol:
Do not consume alcohol while taking Bulgaplin.

Pregnancy and breastfeeding
Bulgaplin should not be used during pregnancy or breastfeeding unless otherwise decided by your doctor. Taking pregabalin during the first trimester of pregnancy may cause congenital malformations in the unborn child requiring treatment. In a Scandinavian countries study, analysis of data from women who took pregabalin during the first three months of pregnancy showed congenital malformations in 6 out of every 100 live-born children, whereas congenital malformations occurred in 4 out of every 100 live-born children in women who were not treated with pregabalin. Reported congenital malformations involved the face (cleft lip and palate), eyes, nervous system (including the brain), kidneys, and genital organs.
Women of childbearing potential should use an effective method of contraception. If you are pregnant or breastfeeding, suspect you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Bulgaplin may cause dizziness, drowsiness, and reduced concentration. Do not drive, operate complex machinery, or perform potentially hazardous activities until you know how this medicine affects your ability to perform these tasks.

3. How to take Bulgaplin

This medicine should always be taken exactly as prescribed by your doctor or pharmacist.
If you are unsure, you should consult your doctor or pharmacist. Do not take a higher dose than
prescribed.
Your doctor will determine the dose most suitable for you.
Bulgaplin is intended for oral use only.
Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorders:

• Take the number of capsules as prescribed by your doctor.
• The recommended dose will range from 150 mg to 600 mg per day.
• Your doctor will inform you whether Bulgaplin should be taken twice or three times daily. If taken twice daily, Bulgaplin should be taken in the morning and evening at the same time each day. If taken three times daily, Bulgaplin should be taken in the morning, at midday, and in the evening at the same time each day. If you feel that Bulgaplin is having too strong or too weak an effect, inform your doctor or pharmacist.

Patients over 65 years of age should take Bulgaplin as directed, unless kidney disease is present.
In patients with impaired kidney function, the doctor may decide on a different dosing schedule and/or adjust the dose.
The capsule should be swallowed whole with water.
Bulgaplin should be taken until your doctor advises you to stop.

Taking more Bulgaplin than prescribed
Inform your doctor or go immediately to the nearest hospital emergency department.
Take the medicine package or bottle with you. After taking more than the prescribed dose of Bulgaplin, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.

If you miss a dose of Bulgaplin
It is important to take Bulgaplin regularly at the same times each day. If you miss a dose, take it as soon as possible, unless it is almost time for your next dose. In that case, continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Bulgaplin
Do not stop taking Bulgaplin suddenly. If you wish to discontinue treatment with Bulgaplin, you should first discuss this with your doctor. Your doctor will advise you on how to do this. If treatment needs to be stopped, it should be done gradually over at least one week.
You should be aware that after stopping short- or long-term treatment with Bulgaplin, certain adverse effects, known as withdrawal symptoms, may occur. These symptoms include sleep disturbances, headache, nausea, anxiety, diarrhoea, flu-like symptoms, seizures, restlessness, depression, thoughts of self-harm or suicide, pain, excessive sweating, and dizziness. These symptoms may be more frequent or more severe if you have been taking Bulgaplin for a long time. If withdrawal symptoms occur, contact your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get 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
• elevated mood, confusion, disorientation, decreased sexual interest, irritability
• difficulty concentrating, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, feeling of fatigue, unusual feeling
• blurred vision, double vision
• vertigo of labyrinthine origin, balance disorders, falls
• dry mouth, constipation, vomiting, bloating, diarrhoea, nausea, feeling of abdominal distension
• difficulty achieving erection
• body swelling, including limbs
• sensation of alcohol intoxication, abnormal gait
• weight gain
• muscle cramps, 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
• changes in self-perception, psychomotor agitation, depression, restlessness, mood changes, difficulty finding the right words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychiatric disorders, difficulty thinking, increased sexual interest, sexual problems, including inability to achieve orgasm, delayed ejaculation
• visual disturbances, unusual eye movements, visual disorders including tunnel vision, perception of flashes, jerky movements, reduced reflexes, increased activity, dizziness upon standing, skin hypersensitivity, loss of taste, burning sensation, intention tremor, disturbances of consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise
• dry eyes, eye swelling, eye pain, weakness of eye movements, tearing, eye irritation
• heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
• sudden reddening of facial skin, sudden hot flushes
• breathing difficulties, dryness of nasal mucosa, sensation of nasal congestion
• increased salivation, heartburn, numbness around the mouth
• sweating, rash, chills, fever
• muscle tremors, joint swelling, muscle stiffness, pain including muscle pain, neck pain
• chest pain
• difficulty urinating or painful urge to urinate, urinary incontinence
• weakness, feeling of thirst, chest tightness
• changes in blood test results and liver function (increased creatine phosphokinase, alanine aminotransferase and aspartate aminotransferase activity, decreased platelet count, neutropenia, increased blood creatinine concentration, decreased blood potassium concentration)
• hypersensitivity, facial swelling, itching, urticaria, catarrh, nosebleeds, cough, snoring
• painful menstruation
• cold hands and feet.
  Rare (may affect up to 1 in 1,000 people):
• altered sense of smell, sensation of image oscillation, altered depth perception, vivid vision, vision loss
• dilated pupils, strabismus
• cold sweats, throat tightness, tongue swelling
• pancreatitis
• difficulty swallowing
• slowed or limited movements
• difficulty with writing
• ascites
• pulmonary edema
• seizures
• ECG changes corresponding to cardiac rhythm disorders
• muscle damage
• nipple discharge, breast enlargement, gynaecomastia in men
• absence of menstruation
• kidney failure, reduced urine volume, urinary retention
• decreased white blood cell count
• inappropriate behaviour, suicidal behaviour, suicidal thoughts
• allergic reactions which may include breathing difficulties, eye inflammation (keratitis), and severe skin reactions characterised by red, flat, disc-shaped or round spots on the trunk, often with blisters in the centre, skin peeling, oral, throat, nose, genital and ocular ulcers. Such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• jaundice (yellowing of the skin and whites of the eyes)
• parkinsonism, i.e. symptoms resembling Parkinson's disease, such as tremor, bradykinesia (reduced movement ability), and rigidity (muscle stiffness).
  Very rare (may affect up to 1 in 10,000 people):
• liver failure
• hepatitis.
  Unknown (frequency cannot be estimated from available data):
• dependence on the medicine Bulgaplin ("drug dependence").
  It should be noted that after discontinuation of short- or long-term treatment with Bulgaplin, certain adverse reactions may occur, known as withdrawal symptoms (see section "Discontinuation of treatment with Bulgaplin").

If facial or tongue swelling occurs, or skin reddening with blisters or skin peeling appears, medical help should be sought immediately.
Some adverse reactions, such as drowsiness, may occur more frequently, as patients with spinal cord injury may be taking other medicines, e.g. analgesics or muscle relaxants, which have similar adverse effects to Bulgaplin, and the severity of these effects may be greater when such medicines are taken concomitantly.
After the medicine was placed on the market, the following adverse reactions have also been reported: breathing difficulties, shallow breathing.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Bulgaplin

Keep the medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the cardboard box or
blister pack after: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines that are no longer required. This will help
protect the environment.

6. Contents of the pack and other information What does Bulgaplin contain?

• The active substance is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 225 mg, or 300 mg of pregabalin.
• Other ingredients: Capsule contents: pregelatinized starch, corn starch, mannitol (E 421), talc. Capsule shell: gelatin, titanium dioxide (E 171), red iron oxide (E 172) (only in 75 mg, 100 mg, 225 mg, and 300 mg capsules), and yellow iron oxide (E 172) (only in 225 mg capsules). Printing ink: shellac, black iron oxide (E 172), propylene glycol (E 1520), ammonium hydroxide 28% (E 527).

What Bulgaplin looks like and contents of the pack
Hard capsule 25 mg: white, 14 mm long, with a black imprint “25” on the body.
Hard capsule 50 mg: white, 16 mm long, with a black imprint “50” on the body.
Hard capsule 75 mg: orange and white, 16 mm long, with a black imprint “75” on the body.
Hard capsule 100 mg: orange, 18 mm long, with a black imprint “100” on the body.
Hard capsule 150 mg: white, 19 mm long, with a black imprint “150” on the body.
Hard capsule 225 mg: red and white, 24 mm long, with a black imprint “225” on the body.
Hard capsule 300 mg: orange and white, 23 mm long, with a black imprint “300” on the body.

Bulgaplin is available in blister packs made of PVC/aluminum foil, in cardboard boxes containing 14, 21, 28, 56, 70, 84, 98, 100, or 112 capsules, and in HDPE bottles containing 60 capsules. HDPE bottles are closed with a PP child-resistant cap. Not all pack sizes may be marketed.

Marketing Authorization Holder
Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer
Pharmathen International S.A.
Industrial Park Sapes
Rodopi Prefecture
Block No 5
69300 Rodopi
Greece
Pharmathen S.A.
Dervenakion 6
15351 Pallini Attiki
Greece
Orion Corporation, Orion Pharma
Orionintie 1
02200 Espoo
Finland
Orion Corporation, Orion Pharma
Joensuunkatu 7
24100 Salo
Finland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]