BULGAPLIN 50 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Bulgaplin, 25 mg, hard capsules
3. Bulgaplin, 50 mg, hard capsules
4. Bulgaplin, 75 mg, hard capsules
5. Bulgaplin, 100 mg, hard capsules
6. Bulgaplin, 150 mg, hard capsules
7. Bulgaplin, 225 mg, hard capsules
8. Bulgaplin, 300 mg, hard capsules
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains
   2. Table of contents of the leaflet
9. What is Bulgaplin and what is it used for
   1. Neuropathic pain of peripheral and central origin
   2. Epilepsy
   3. Generalized anxiety disorder
10. Important information before taking Bulgaplin
    1. When not to take Bulgaplin
    2. Warnings and precautions
    3. Before taking this medicine, you should tell your doctor if you have a history of heart disease.
    4. Children and adolescents
    5. Bulgaplin and other medicines
    6. Taking Bulgaplin with food, drink, and alcohol
    7. Pregnancy and breastfeeding
    8. Driving and using machines
11. How to take Bulgaplin
    1. Neuropathic pain of peripheral and central origin, epilepsy, or generalized anxiety disorder:
    2. Taking a higher dose of Bulgaplin than prescribed
    3. Missing a dose of Bulgaplin
    4. Stopping treatment with Bulgaplin
12. Possible side effects
    1. If you experience swelling of the face or tongue, or redness of the skin and appearance of blisters or peeling of the skin, you should seek medical help immediately.
    2. Reporting side effects
13. How to store Bulgaplin
14. Contents of the pack and other information What Bulgaplin contains
    1. What Bulgaplin looks like and contents of the pack
    2. Marketing authorization holder
    3. Manufacturer
    4. Date of last revision of the leaflet:

Leaflet attached to the packaging: 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

You should carefully read the contents of the leaflet before taking the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Bulgaplin and what is it used for
• 2. Important information 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 is Bulgaplin and what is it used for

Bulgaplin belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalized anxiety disorder in adults.

Neuropathic pain of peripheral and central origin

Bulgaplin is used to treat long-term pain caused by nerve damage. Many different diseases, such as diabetes or shingles, can cause peripheral neuropathic pain. The pain can be described as a feeling of heat, burning, throbbing, shooting, stabbing, as sharp pain, cramps, aching, tingling, or numbness. Peripheral and central neuropathic pain can also be associated with mood changes, sleep disturbances, fatigue, which can affect the patient's physical and social functioning and overall quality of life.

Epilepsy

Bulgaplin is used to treat certain types of epilepsy (partial seizures, which may or may not be secondarily generalized) in adults. Your doctor may prescribe Bulgaplin if your current treatment does not fully control your condition. Bulgaplin should always be used as an add-on therapy to your current treatment. Bulgaplin should not be used as monotherapy, but always in combination with other anti-epileptic drugs.

Generalized anxiety disorder

Bulgaplin is used to treat generalized anxiety disorder (GAD). The symptoms of GAD include prolonged, excessive anxiety and worry that is difficult to control. GAD can also cause restlessness, feeling on edge or irritability, fatigue, difficulty concentrating or feeling "empty in the head", sleep disturbances. These symptoms are different from the stresses and tensions of everyday life.

2. Important information 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

You should discuss this with your doctor or pharmacist before taking Bulgaplin.

• Some patients taking pregabalin have experienced symptoms suggesting an allergic reaction. These symptoms included swelling of the face, lips, tongue, and throat, as well as a widespread rash. If you experience any of these symptoms, you should contact your doctor immediately.
• Pregabalin has been associated with severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. If you experience any of the symptoms of severe skin reactions listed in section 4, you should stop taking pregabalin and seek medical help immediately.
• Pregabalin has been associated with dizziness and somnolence: this may increase the risk of accidental injury (falls) in older people. Therefore, you should exercise caution until you are used to the effects of the medicine.
• Pregabalin may cause blurred vision, double vision, or other changes in vision. If you experience any changes in your vision, you should tell your doctor immediately.
• In patients with diabetes, weight gain may occur during treatment with pregabalin. This may require a change in anti-diabetic treatment.
• Some side effects, such as drowsiness, may occur more frequently, as patients with spinal cord injury may be taking other medicines, such as painkillers or muscle relaxants, which have similar side effects to pregabalin, and the severity of these effects may be greater when these medicines are taken at the same time.
• There have been reports of heart failure in some patients taking pregabalin; these were mainly older patients with pre-existing heart conditions.

Before taking this medicine, you should tell your doctor if you have a history of heart disease.

• There have been reports of kidney failure in some patients taking pregabalin. If you experience a decrease in urine output while taking Bulgaplin, you should tell your doctor, as stopping the medicine may cause the symptom to resolve.
• A small number of patients taking anti-epileptic drugs, such as Bulgaplin, have had thoughts of self-harm or suicide, or have exhibited suicidal behavior. If you have ever had such thoughts or behavior, you should contact your doctor immediately.
• If Bulgaplin is taken with other medicines that can cause constipation (such as some painkillers), gastrointestinal problems (such as constipation, obstruction, or paralysis of the intestines) may occur. You should tell your doctor if you experience constipation, especially if you are prone to it.
• Before taking this medicine, you should tell your doctor if you have ever abused or been dependent on alcohol, prescription drugs, or any illegal psychoactive substances; this may indicate that you are at increased risk of dependence on Bulgaplin.

if you experience any of these symptoms, you should talk to your doctor to discuss the best course of treatment, including when to stop taking the medicine 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.

Bulgaplin and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.

• Bulgaplin and some other medicines may interact with each other (interact). When taken with other medicines that have a sedating effect (e.g., opioids), Bulgaplin may increase these effects and cause respiratory failure, coma, and death. The degree of dizziness, drowsiness, and decreased concentration may increase if Bulgaplin is taken with medicines containing:
• oxycodone (a painkiller)
• lorazepam (a medicine used for anxiety)
• alcohol. Bulgaplin may be taken with oral contraceptives.

Taking Bulgaplin with food, drink, and alcohol

Bulgaplin capsules can be taken with or without food.

Alcohol:

You should not drink alcohol while taking Bulgaplin.

Pregnancy and breastfeeding

Bulgaplin should not be taken during pregnancy or breastfeeding, unless your doctor decides otherwise. Taking pregabalin during the first 3 months of pregnancy may cause birth defects in the unborn baby that require treatment. In a Scandinavian study, analysis of data from women who took pregabalin during the first 3 months of pregnancy showed birth defects in 6 out of every 100 babies born, whereas in women who were not treated with pregabalin, birth defects occurred in 4 out of every 100 babies born. The reported birth defects included facial defects (cleft lip and palate), eye defects, central nervous system defects (including brain defects), kidney defects, and genital defects. Women of childbearing age should use effective contraception. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Bulgaplin may cause dizziness, drowsiness, and decreased concentration. You should not drive, operate complex machinery, or perform potentially hazardous activities until you have ascertained the effects of this medicine.

3. How to take Bulgaplin

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.

Your doctor will determine the dose that is right for you.

Bulgaplin is for oral use only.

Neuropathic pain of peripheral and central origin, epilepsy, or generalized anxiety disorder:

• You should take the number of capsules as prescribed by your doctor.
• The dose prescribed for you will be between 150 mg and 600 mg per day.
• Your doctor will tell you if you should take Bulgaplin twice or three times a day. If you take it twice a day, you should take it in the morning and evening at the same time every day. If you take it three times a day, you should take it in the morning, at noon, and in the evening at the same time every day. If you feel that Bulgaplin is too strong or too weak, you should tell your doctor or pharmacist.

Patient over 65 years of age should take Bulgaplin as described, unless they have kidney disease.

In patients with impaired renal function, your doctor may decide to adjust the dose and/or adjust the dosing schedule.

The capsule should be swallowed whole with water.

You should take Bulgaplin until your doctor tells you to stop.

Taking a higher dose of Bulgaplin than prescribed

You should tell your doctor or go to the nearest hospital emergency department immediately. You should take the packaging or bottle of Bulgaplin with you. After taking a higher dose of Bulgaplin than prescribed, you may feel drowsy, confused, agitated, or restless. There have also been reports of seizures and loss of consciousness (coma).

Missing a dose of Bulgaplin

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

Stopping treatment with Bulgaplin

You should not stop taking Bulgaplin suddenly. If you want to stop taking Bulgaplin, you should talk to your doctor first. Your doctor will tell you how to do this. If treatment is to be stopped, it should be done gradually over a minimum of 1 week.

You should be aware that after stopping short-term or long-term treatment with Bulgaplin, certain side effects may occur, known as withdrawal symptoms. These symptoms include sleep disturbances, headache, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, excessive sweating, and dizziness. These symptoms may be more frequent or more severe if you have taken Bulgaplin for a longer period. If you experience withdrawal symptoms, you should contact your doctor.

If you have any further questions on the use of this product, you should 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 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, loss of memory, tremors, speech disturbances, tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling unwell
• blurred vision, double vision
• vertigo of labyrinthine origin, balance disturbances, falls
• dry mouth, constipation, vomiting, bloating, diarrhea, nausea, feeling of abdominal distension
• difficulty achieving erection
• edema of the body, including limbs
• feeling of intoxication, ataxia
• weight gain
• muscle spasms, joint pain, back pain, limb pain
• throat pain. Uncommon (may affect up to 1 in 100 people):
• loss of appetite, weight loss, low blood sugar, high blood sugar
• changes in self-perception, restlessness, depression, agitation, mood swings, difficulty finding the right words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, mental disorders, difficulty thinking, increased sexual interest, sexual problems, including inability to achieve orgasm, delayed ejaculation
• changes in vision, abnormal eye movements, vision disturbances, including tunnel vision, flashes of light, nystagmus, decreased reflexes, increased activity, dizziness on standing, skin hypersensitivity, loss of taste, feeling of burning, tremor on movement, impaired consciousness, loss of consciousness, syncope, increased sensitivity to noise, malaise
• dry eyes, eye edema, eye pain, decreased eye movements, lacrimation, eye irritation
• arrhythmias, tachycardia, hypotension, hypertension, changes in heart rate, heart failure
• flushing, hot flushes
• breathing difficulties, dryness of the nasal mucosa, feeling of a blocked nose
• increased salivation, heartburn, feeling of numbness around the mouth
• sweating, rash, chills, fever
• muscle twitching, joint swelling, muscle stiffness, pain, including muscle pain, neck pain
• chest pain
• difficulty urinating or painful urination, urinary incontinence
• weakness, feeling of thirst, chest tightness
• changes in blood test results and liver function (increased creatine phosphokinase activity, alanine aminotransferase, and aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine levels in the blood, decreased potassium levels in the blood)
• hypersensitivity, facial edema, pruritus, urticaria, rhinitis, epistaxis, cough, snoring
• painful menstruation
• coldness of hands and feet. Rare (may affect up to 1 in 1,000 people):
• changed sense of smell, feeling of rocking, changed sense of depth, bright vision, loss of vision
• dilated pupils, strabismus
• cold sweats, throat constriction, tongue edema
• pancreatitis
• difficulty swallowing
• slow or restricted movements
• difficulty writing
• ascites
• fluid in the lungs
• seizures
• changes in ECG tracing corresponding to arrhythmias
• muscle damage
• galactorrhea, gynecomastia, breast enlargement in men
• amenorrhea
• renal failure, decreased urine output, urinary retention
• decreased white blood cell count
• inappropriate behavior, suicidal behavior, suicidal thoughts
• allergic reactions, which may include difficulty breathing, eye inflammation (keratitis), and severe skin reactions, characterized by red, flat, plate-like, or round patches on the trunk, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of 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 similar to those of Parkinson's disease, such as tremors, slowed movement (decreased ability to move), and stiffness (muscle stiffness). Very rare (may affect up to 1 in 10,000 people):
• liver failure
• hepatitis. Unknown (frequency cannot be estimated from the available data):
• dependence on Bulgaplin (drug dependence) You should be aware that after stopping short-term or long-term treatment with Bulgaplin, certain side effects may occur, known as withdrawal symptoms (see "Stopping treatment with Bulgaplin").

If you experience swelling of the face or tongue, or redness of the skin and appearance of blisters or peeling of the skin, you should seek medical help immediately.

Some side effects, such as drowsiness, may occur more frequently, as patients with spinal cord injury may be taking other medicines, such as painkillers or muscle relaxants, which have similar side effects to Bulgaplin, and the severity of these effects may be greater when these medicines are taken at the same time.

After the medicine was placed on the market, the following side effects were also reported: breathing difficulties, shallow breathing.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bulgaplin

The medicine should be stored out of the sight and reach of children.

There are no special precautions for storage.

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

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information What Bulgaplin contains

• 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.
• The other ingredients are: capsule content: maize starch, maize starch, mannitol (E 421), talc. capsule shell: gelatin, titanium dioxide (E 171), iron oxide red (E 172) (only 75 mg, 100 mg, 225 mg, and 300 mg capsules) and iron oxide yellow (E 172) (only 225 mg capsules). ink: shellac, iron oxide black (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 black printing "25" on the body.

Hard capsule 50 mg:white, 16 mm long, with black printing "50" on the body.

Hard capsule 75 mg:orange-white, 16 mm long, with black printing "75" on the body.

Hard capsule 100 mg:orange, 18 mm long, with black printing "100" on the body.

Hard capsule 150 mg:white, 19 mm long, with black printing "150" on the body.

Hard capsule 225 mg:red-white, 24 mm long, with black printing "225" on the body.

Hard capsule 300 mg:orange-white, 23 mm long, with black printing "300" on the body.

Bulgaplin is available in PVC/Aluminum blisters in cartons 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 cap that is child-resistant.

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

To obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:

Orion Pharma Poland Sp. z o. o.

[email protected]

Date of last revision of the leaflet: