Bulgaplin

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, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 are or are not secondarily generalized) in adults. The doctor may prescribe Bulgaplin if the current treatment does not fully control the course of the disease. Bulgaplin should always be used as an add-on therapy to the currently used treatment. Bulgaplin should not be used as monotherapy, but always in combination with other antiepileptic drugs.

Generalized anxiety disorder

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

2. Important information before taking Bulgaplin

When not to take Bulgaplin

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

Warnings and precautions

Before starting to take Bulgaplin, the patient should discuss it with their doctor or pharmacist.

• In some patients taking pregabalin, symptoms of an allergic reaction have occurred. These symptoms included swelling of the face, lips, tongue, and throat, as well as a widespread skin rash. If any of these symptoms occur, the patient should contact their doctor immediately.
• Pregabalin has been associated with severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. If the patient experiences any symptoms of severe skin reactions, they 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 the elderly. Therefore, the patient should be cautious until they are aware of the effects of the medicine.
• Pregabalin may cause blurred vision, loss of vision, or other vision disturbances, most of which are temporary. If the patient experiences any changes in vision, they should inform their doctor immediately.
• In patients with diabetes, who gain weight while taking pregabalin, it may be necessary to adjust their antidiabetic treatment.
• Some side effects, such as somnolence, may occur more frequently because patients with spinal cord injury may be taking other medicines, e.g., painkillers or muscle relaxants, which have similar side effects to pregabalin, and the intensity of these effects may be greater when such medicines are taken at the same time.
• There have been reports of heart failure in some patients taking pregabalin; these were mainly elderly patients with cardiovascular disorders.

Before taking this medicine, the patient should inform their doctor about any history of heart disease.

• There have been reports of kidney failure in some patients taking pregabalin. If the patient notices a decrease in urine output while taking Bulgaplin, they should inform their doctor, as stopping the medicine may cause the symptom to resolve.
• A small number of patients taking antiepileptic drugs, such as Bulgaplin, have had thoughts of self-harm or suicide, or have shown suicidal behavior. If the patient has ever had such thoughts or behavior, they should contact their 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. The patient should inform their doctor if they experience constipation, especially if they are prone to it.
• Before starting to take this medicine, the patient should inform their doctor if they have ever abused or been dependent on alcohol, prescription drugs, or any illegal psychoactive substances; this may indicate an increased risk of dependence on Bulgaplin.

If the patient notices any of these symptoms, they should talk to their doctor to discuss the best course of treatment, including when to stop taking the medicine and how to do it safely.

Children and adolescents

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

Bulgaplin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take. Bulgaplin and some medicines can interact with each other (interactions). 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, somnolence, 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: The patient should not drink alcohol while taking Bulgaplin.

Pregnancy and breastfeeding

Bulgaplin should not be taken during pregnancy or breastfeeding, unless the 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, nervous system defects (including brain defects), kidney defects, and genital defects. Women of childbearing age should use effective contraception. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Bulgaplin may cause dizziness, somnolence, and decreased concentration. The patient should not drive, operate complex machines, or perform potentially hazardous activities until they have ascertained the effects of the medicine.

3. How to take Bulgaplin

This medicine should always be taken exactly as the doctor or pharmacist has told the patient. If the patient is not sure, they should ask their doctor or pharmacist. The patient should not take more medicine than prescribed.

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

• The patient should take the number of capsules prescribed by their doctor.
• The recommended dose for the patient will be between 150 mg and 600 mg per day.
• The doctor will inform the patient whether to take Bulgaplin twice or three times a day. If taken twice a day, Bulgaplin should be taken in the morning and evening at the same time every day. If taken three times a day, Bulgaplin should be taken in the morning, at noon, and in the evening at the same time every day. If the patient feels that Bulgaplin is too strong or too weak, they should inform their doctor or pharmacist.

Patient over 65 years of age should take Bulgaplin according to the presented schedule unless they have kidney disease. In patients with impaired renal function, the doctor may decide on a different dosing schedule and/or change the dose of the medicine. The capsule should be swallowed whole with water. Bulgaplin should be taken until the doctor decides to stop the treatment.

Taking a higher dose of Bulgaplin than recommended

The patient should inform their doctor or go to the nearest hospital emergency department immediately. The patient should take the packaging or bottle of Bulgaplin with them. After taking a higher dose of Bulgaplin than recommended, the patient 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 a dose is missed, it should be taken as soon as possible, unless it is close to the time for the next dose. In this case, the patient should continue treatment according to the prescribed schedule. The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Bulgaplin

The patient should not stop taking Bulgaplin suddenly. If the patient wants to stop taking Bulgaplin, they should talk to their doctor first. The doctor will tell them how to do it. If treatment needs to be stopped, it should be done gradually over at least one week. The patient 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 severe if the patient has taken Bulgaplin for a longer period. If withdrawal symptoms occur, the patient should contact their doctor. If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bulgaplin can cause side effects, although not everybody gets them. Very common (may affect more than 1 in 10 people):

• -dizziness, somnolence, headache. Common (may affect up to 1 in 10 people):
• increased appetite
• elevated mood, confusion, disorientation, decreased sexual interest, irritability
• difficulty concentrating, clumsiness, memory disturbances, memory loss, tremors, speech disturbances, feeling of tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling of malaise
• blurred vision, double vision
• vertigo of labyrinthine origin, balance disturbances, falls
• dry mouth, constipation, vomiting, bloating, diarrhea, nausea, feeling of abdominal distension
• erectile dysfunction
• edema of the body, including limbs
• feeling of intoxication, ataxia
• weight gain
• muscle cramps, 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 changes, difficulty finding the right words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychotic 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 when standing up, hypersensitivity of the skin, loss of taste, feeling of burning, tremor when performing movements, disturbances of consciousness, loss of consciousness, syncope, increased sensitivity to noise, malaise
• dry eyes, eye edema, eye pain, decreased eye movements, lacrimation, eye irritation
• heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
• flushing, hot flushes
• breathing difficulties, feeling of 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, itching, urticaria, rhinitis, epistaxis, cough, snoring
• painful menstruation
• chilliness 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
• pupil dilation, strabismus
• cold sweats, throat constriction, tongue edema
• pancreatitis
• difficulty swallowing
• slow or limited movements
• difficulty writing
• ascites
• fluid in the lungs
• seizures
• changes in ECG tracing corresponding to heart rhythm disturbances
• muscle damage
• galactorrhea, gynecomastia, breast enlargement in men
• amenorrhea
• kidney 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 torso, often with blisters or 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 Parkinson's disease, such as tremors, slowed movement (reduced 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”)

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

Some side effects, such as somnolence, may occur more frequently because patients with spinal cord injury may be taking other medicines, e.g., painkillers or muscle relaxants, which have similar side effects to Bulgaplin, and the intensity of these effects may be greater when such 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 the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Bulgaplin

The medicine should be stored out of sight and reach of children. There are no special precautions for storing the medicine. Do not take this medicine after the expiry date stated on the carton or blister after „EXP”. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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: corn 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), ammonia 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 protects against children. 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 more information about this medicine, the patient 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