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

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

Information for the patient.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What is Bulgaplin and what is it used for
• 2. Before you take 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 peripheral and central

Bulgaplin is used to treat long-term pain caused by damage to the nerves. Many different diseases such as diabetes or shingles can cause peripheral neuropathic pain. The pain can be described as a feeling of hotness, burning, pulsating, shooting, stabbing, sharp, crampy, 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, with or without secondary generalization) in adults. Your doctor may prescribe Bulgaplin if your current treatment does not fully control your condition. Bulgaplin should always be used in addition to your current treatment. Bulgaplin must not be used as a sole treatment, but always in combination with other anti-epileptic medicines.

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, difficulty concentrating or feeling like your mind is blank, or sleep disturbances. These symptoms are different from the stress and tension of everyday life.

2. Before you take Bulgaplin

Do not 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 taking Bulgaplin, tell your doctor or pharmacist if you have any medical conditions, if you are taking any other medicines, or if you have any allergies.

• Some patients taking pregabalin have experienced symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as a rash. If you experience any of these symptoms, contact your doctor immediately.
• Pregabalin has been associated with severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. If you experience any symptoms of severe skin reactions, stop taking pregabalin and seek medical attention immediately.
• Pregabalin has been associated with dizziness and somnolence, which may increase the risk of accidental injury (falls) in elderly patients. Therefore, you should exercise caution until you are familiar with the effects of this medicine.
• Pregabalin may cause blurred vision, double vision, or other changes in vision. If you experience any changes in your vision, contact your doctor immediately.
• In patients with diabetes, weight gain may occur during treatment with pregabalin, which may require a change in antidiabetic treatment.
• Some side effects, such as drowsiness, may occur more frequently because 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 side effects may be greater when these medicines are taken together.
• There have been reports of heart failure in some patients taking pregabalin; these patients were mostly elderly with pre-existing cardiovascular conditions.

Before taking this medicine, 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, contact your doctor, as stopping the medicine may resolve this symptom.
• A small number of patients taking antiepileptic medicines, such as Bulgaplin, have had thoughts of harming themselves or others, or have experienced suicidal behavior. If you experience any such thoughts or behaviors, contact your doctor immediately.
• If Bulgaplin is taken with other medicines that can cause constipation (such as certain painkillers), gastrointestinal problems (such as constipation, obstruction, or paralytic ileus) may occur. Tell your doctor if you experience constipation, especially if you are prone to it.
• Before taking this medicine, tell your doctor if you have a history of substance abuse or dependence on alcohol, prescription medicines, or illegal psychoactive substances; this may indicate an increased risk of dependence on Bulgaplin.

If you are taking this medicine and experience any of the following symptoms, it may indicate dependence: the need to take the medicine for a longer period than prescribed, 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 taking the medicine or control its use, feeling unwell after stopping the medicine and feeling better after taking it again.

• If you experience any of these symptoms, talk to your doctor to discuss the best course of treatment, including when to stop taking the medicine and how to do so safely.
• There have been reports of seizures during treatment with pregabalin or shortly after stopping treatment. If you experience seizures, contact your doctor immediately.
• There have been reports of brain dysfunction (encephalopathy) in some patients with other conditions who took pregabalin. Tell your doctor about any serious illnesses you have had, including liver or kidney disease.
• There have been reports of breathing difficulties. If you experience respiratory problems, contact your doctor.

Dependence: Some people may become dependent on Bulgaplin (need to continue taking the medicine). After stopping treatment with Bulgaplin, withdrawal symptoms may occur (see section 3 "How to take Bulgaplin" and "Stopping Bulgaplin"). If you are concerned about becoming dependent on Bulgaplin, talk to your doctor.

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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those you have bought without a prescription.

• Bulgaplin and some other medicines may affect each other. When taken with other medicines that have a sedating effect (such as opioids), Bulgaplin may increase these effects and cause respiratory failure, coma, and death. The severity 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: Do 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 three months of pregnancy may cause birth defects in the unborn baby. A study in Scandinavian countries analyzed data from women who took pregabalin during the first three months of pregnancy and found birth defects in 6 out of every 100 babies born, while in women who did not take 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, brain and spinal cord defects, kidney and genital defects. Women of childbearing age should use effective contraception. If you are pregnant, think 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 decreased concentration. Do not drive, operate complex machinery, or perform potentially hazardous activities until you know how this medicine affects you.

3. How to take Bulgaplin

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Do not take more than the prescribed dose.

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

• Take the number of capsules as prescribed by your doctor.
• The dose 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, take it in the morning and evening at the same time each day. If you take it three times a day, take it in the morning, at noon, and in the evening at the same time each day. If you think that the effect of Bulgaplin is too strong or too weak, talk to your doctor or pharmacist.

Patients over 65 years of age should take Bulgaplin as prescribed, unless they have kidney problems. Your doctor may decide to adjust the dose or dosing schedule if you have kidney problems. Swallow the capsule whole with water. Take Bulgaplin until your doctor tells you to stop.

If you take more Bulgaplin than you should

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

If you forget to take Bulgaplin

It is important to take Bulgaplin regularly at the same times each day. If you forget a dose, take it as soon as you remember, unless it is time for your next dose. In this case, continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

Stopping Bulgaplin

Do not stop taking Bulgaplin suddenly. If you want to stop taking Bulgaplin, talk to your doctor first. Your doctor will tell you how to stop taking it safely. If treatment needs to be stopped, it should be done gradually over at least one week. You should know that after stopping short-term or long-term treatment with Bulgaplin, you may experience certain side effects, 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 you have taken Bulgaplin for a longer period. If you experience withdrawal symptoms, contact your doctor.

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, difficulty speaking, tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal
• blurred vision, double vision
• vertigo, balance disorder, falls
• dry mouth, constipation, vomiting, bloating, diarrhea, nausea
• erectile dysfunction
• edema, including peripheral edema
• feeling drunk, 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 changes, difficulty finding 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, vertigo when standing up, skin hypersensitivity, loss of taste, burning sensation, tremors when moving, impaired consciousness, loss of consciousness, fainting, 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, 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, alanine aminotransferase, and aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine, decreased potassium)
• hypersensitivity, facial edema, itching, urticaria, rhinitis, epistaxis, cough, snoring
• painful menstruation
• coldness of hands and feet. Rare (may affect up to 1 in 1,000 people):
• altered smell, feeling of rocking, altered sense of depth, bright vision, loss of vision
• dilated pupils, 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 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, target-like, or circular patches on the torso, often with blisters or peeling of the skin, mouth ulcers, genital ulcers, and eye inflammation. The occurrence of such severe skin reactions 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, characterized by symptoms similar to Parkinson's disease, such as tremors, slowed movements (reduced mobility), 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, you may experience certain side effects, known as withdrawal symptoms (see section "Stopping Bulgaplin").

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

Some side effects, such as drowsiness, may occur more frequently because 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 side effects may be greater when these medicines are taken together. After the medicine was placed on the market, the following side effects were also reported: breathing difficulties, shallow breathing.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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, you can help provide more information on the safety of this medicine.

5. How to store Bulgaplin

Keep this 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 which is 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. Ask your pharmacist how to dispose of medicines no longer required. These measures 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, mannitol (E 421), talc. capsule shell: gelatin, titanium dioxide (E 171), iron oxide red (E 172) (only for 75 mg, 100 mg, 225 mg, and 300 mg capsules), and iron oxide yellow (E 172) (only for 225 mg capsules). ink: shellac, iron oxide black (E 172), propylene glycol (E 1520), ammonia solution 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. The 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

For further information on this medicine, 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: