Tabagine

Leaflet attached to the packaging: information for the user

Tabagine, 75 mg, hard capsules

Tabagine, 150 mg, hard capsules

Tabagine, 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 doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Tabagine and what is it used for

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

Neuropathic pain of peripheral and central origin:

The medicine 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, pulsation, shooting, stabbing, as sharp pain, cramps, soreness, 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:

Tabagine is used in adults for certain types of epilepsy (partial seizures, which may or may not be secondarily generalized). The doctor may prescribe this medicine if the previously used therapy does not fully control the course of the disease. Tabagine should always be added to the currently used treatment. This medicine should not be used as the only one (in monotherapy), but always in combination with other antiepileptic drugs.

Generalized anxiety disorders:

Tabagine is used in generalized anxiety disorders (English: Generalized Anxiety Disorder - GAD). The symptoms include prolonged, excessive anxiety and worry that is difficult to control. Generalized anxiety disorders can also cause restlessness, nervousness, or a feeling of being on edge, easy fatigability, difficulty concentrating or a 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 Tabagine

When not to take Tabagine:

• 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 Tabagine, the patient should discuss it with their doctor or pharmacist.

• In some patients taking pregabalin, symptoms suggesting an allergic reaction have occurred. These symptoms included swelling of the face, lips, tongue, and throat, as well as a 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 of the symptoms of serious skin reactions listed in section 4, they should stop taking pregabalin and seek medical help immediately.
• Taking pregabalin has been associated with dizziness and somnolence: this may lead to more frequent accidental injuries (falls) in elderly people. Therefore, caution should be exercised until the patient is aware of the possible effects of the medicine.
• Taking pregabalin may cause blurred vision, loss of vision, or other vision disturbances, most of which are temporary. If any changes in vision occur, the patient 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 severity 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 this medicine, they should inform their doctor, as stopping the medicine may cause the symptom to disappear.
• Some patients taking antiepileptic drugs such as pregabalin have had thoughts of self-harm or suicide. If the patient has ever had such thoughts or behaviors, they should contact their doctor immediately.
• If pregabalin is taken with other medicines that can cause constipation (such as some painkillers), gastrointestinal disturbances (e.g., 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 narcotics, as this may indicate a higher risk of dependence on pregabalin.
• There have been reports of seizures during pregabalin treatment or shortly after stopping treatment. If seizures occur, the patient should contact their doctor immediately.
• There have been reports of brain function impairment (encephalopathy) in some patients with other diseases. The patient should inform their doctor about all serious diseases they have had, including liver or kidney disorders.

The patient should inform their doctor about all serious diseases they have had.

• There have been reports of breathing difficulties. If the patient has nervous system, respiratory, kidney, or other disorders, or if they are over 65 years old, the doctor may recommend a different dosing schedule. If the patient experiences breathing difficulties or shallow breathing, they should contact their doctor.

Dependence

Some people may become dependent on pregabalin (need to continue taking the medicine). After stopping pregabalin, withdrawal symptoms may occur (see section 3 "How to take Tabagine" and "Stopping Tabagine"). If the patient is concerned that they may become dependent on pregabalin, they should talk to their doctor. If the patient experiences any of the following symptoms while taking pregabalin, it may indicate dependence:

• Need to take the medicine for a longer period than prescribed by the doctor
• Feeling the need to take a higher dose than prescribed
• Taking the medicine for reasons other than those for which it was prescribed
• Repeatedly attempting to stop or control the use of the medicine without success
• Feeling unwell after stopping the medicine and feeling better after taking it again

If the patient experiences 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.

Tabagine and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Tabagine and some medicines may interact with each other. Pregabalin taken with medicines that have a sedative effect (including opioids) may enhance these effects, leading to respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if pregabalin is taken with medicines containing:

• oxycodone (a painkiller)
• lorazepam (a medicine used for anxiety)
• alcohol.

Tabagine can be taken with oral contraceptives.

Taking Tabagine with food, drink, and alcohol

The capsules can be taken with or without food. The patient should not drink alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

Tabagine should not be taken during pregnancy or breastfeeding, unless the doctor recommends it. Taking pregabalin during the first 3 months of pregnancy may cause birth defects in the unborn child. In a study analyzing data from women in Scandinavian countries who took pregabalin during the first 3 months of pregnancy, 6 out of 100 children had such birth defects. For comparison, in a study of 4 out of 100 children born to women who did not take pregabalin. There have been reports of facial abnormalities (cleft lip and palate), eye, nervous system (including brain), kidney, and genital abnormalities. Women of childbearing age must use effective contraception. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Pregabalin may cause dizziness, somnolence, and decreased concentration. The patient should not drive a car, operate complex machines, or perform potentially hazardous activities until they know how the medicine affects their ability to perform these activities.

Tabagine contains sodium and mannitol

The medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, which means the medicine is considered "sodium-free". Mannitol may have a mild laxative effect.

3. How to take Tabagine

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. The patient should not take more of the medicine than prescribed. The doctor will determine the dose that is right for the patient. The medicine is for oral use only.

Epilepsy, neuropathic pain of peripheral and central origin, or generalized anxiety disorders:

• The patient should take the number of capsules prescribed by their doctor.
• The dose will usually be between 150 mg and 600 mg per day.
• The doctor will inform the patient whether to take Tabagine twice or three times a day. If taken twice a day, the medicine should be taken in the morning and evening at the same time. If taken three times a day, the medicine should be taken in the morning, at noon, and in the evening at the same time.

If the patient feels that the medicine is too strong or too weak, they should inform their doctor or pharmacist. Patients over 65 years of age should take the medicine 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 and washed down with water. The medicine should be taken for as long as the doctor recommends, and the treatment can only be stopped on the doctor's advice.

Taking a higher dose of Tabagine than recommended

The patient should inform their doctor or go to the nearest hospital emergency department immediately. The patient should take the packaging of the medicine with them. After taking a higher dose than recommended, the patient may feel sleepy, confused, excited, or restless. There have also been reports of seizures.

Missing a dose of Tabagine

It is important to take the medicine regularly at the same times of the day. If a dose is missed, the patient should take it as soon as possible, unless it is almost 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 the missed capsules.

Stopping Tabagine

The patient should not stop taking the medicine suddenly. If the patient wants to stop taking the medicine, they should first talk to their doctor. The doctor will inform the patient how to do it. If the 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 pregabalin, 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 Tabagine for a longer period. If withdrawal symptoms occur, the patient should contact their doctor. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tabagine can cause side effects, although not everybody gets them.

Serious side effects:

If the patient experiences any of the following side effects, they should stop taking the medicine and contact their doctor or go to the nearest hospital immediately, as urgent medical attention may be necessary.

• Hypersensitivity (not very common, may affect up to 1 in 100 people) and allergic reactions (which may include swelling of the face, lips, tongue, and throat, as well as rash) (rare, may affect up to 1 in 1,000 people)
• Serious skin reaction characterized by red, flat, round, or oval patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of such serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) (rare, may affect up to 1 in 1,000 people). If the patient experiences swelling of the face or tongue, or if the skin turns red and blisters appear or the skin peels, they should seek medical attention immediately.
• Pancreatitis (including symptoms: severe pain in the upper abdomen, often with nausea and vomiting) (rare, may affect up to 1 in 1,000 people)

Pancreatitis (including symptoms: severe pain in the upper abdomen, often with nausea and vomiting) (rare, may affect up to 1 in 1,000 people)

Other side effects:

Very common side effects (may affect more than 1 in 10 people):

• dizziness, somnolence, headaches.

Common side effects (may affect up to 1 in 10 people):

• increased appetite;
• feeling of euphoria, confusion, disorientation, decreased sexual interest, irritability
• difficulty concentrating, clumsiness, memory disturbances, memory loss, tremors, speech disturbances, feeling of tingling, numbness, sedation, lethargy, insomnia, feeling of fatigue, strange feeling;
• blurred vision, double vision;
• dizziness, balance disturbances, falls;
• dry mouth, constipation, vomiting, bloating, diarrhea, nausea, feeling of abdominal distension;
• difficulty achieving an erection;
• edema of the body, including limbs;
• feeling of intoxication, abnormal gait;
• weight gain;
• muscle spasms, joint pain, back pain, limb pain, neck stiffness;
• sore throat.

Uncommon side effects (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, excitement, mood changes, 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, sudden movements, uncontrolled movements of the limbs, weakened reflexes, increased activity, dizziness when standing, increased skin sensitivity, loss of taste, burning sensation, tremors when moving, impaired consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise
• dry eyes, eye swelling, eye pain, weakened eye movements, tearing, eye irritation;
• heart rhythm disturbances, accelerated heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure;
• sudden flushing of the skin of the face, sudden hot flashes;
• breathing difficulties, feeling of dryness in the nose, feeling of a blocked nose;
• cough, facial swelling, hives, itching, runny nose, nosebleeds, snoring;
• increased salivation, heartburn, feeling of numbness around the mouth;
• sweating, rash, chills, fever;
• coldness of hands and feet;
• muscle tremors, joint swelling, muscle stiffness, pain, including muscle pain, neck pain;
• difficulty urinating or painful urination, urinary incontinence;
• weakness, thirst, chest tightness;
• chest pain;
• painful menstruation;
• generalized edema;
• changes in blood test results and liver function (increased creatine phosphokinase activity, alanine aminotransferase, and aspartate aminotransferase, decreased platelet count, increased creatinine levels in the blood, neutropenia).

Rare side effects (may affect up to 1 in 1,000 people):

• changes in heart rhythm;
• changes in smell, sensation of rocking, changes in depth perception, bright vision, loss of vision;
• dilated pupils, strabismus;
• eye inflammation (keratitis);
• cold sweats, tightness in the throat, tongue swelling;
• difficulty swallowing;
• slow or limited movements;
• difficulty writing;
• fluid in the lungs;
• seizures;
• changes in ECG recordings corresponding to heart rhythm disturbances;
• ascites;
• muscle damage;
• breast discharge, breast enlargement, gynecomastia;
• amenorrhea;
• kidney failure, decreased urine output, urinary retention;
• decreased white blood cell count;
• inappropriate behavior;
• 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.

Frequency not known: frequency cannot be estimated from the available data

• Dependence on pregabalin ("drug dependence")

The patient should be aware that after stopping short-term or long-term treatment with pregabalin, side effects may occur, known as withdrawal symptoms (see section "Stopping Tabagine"). 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 Tabagine, and the severity of these effects may be greater when such medicines are taken at the same time. Side effects reported after the medicine was placed on the market: breathing difficulties, shallow breathing. Reporting side effects If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 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 Tabagine

The medicine should be stored out of sight and reach of children. The medicine should not be taken after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month stated. The batch number is stated after "Lot". There are no special precautions for storing the medicine. After opening the bottle of capsules, the capsules should be used within 30 days. 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 Tabagine contains

The active substance of the medicine is pregabalin. Each hard capsule contains 75 mg, 150 mg, or 300 mg of pregabalin. The other ingredients are:

• mannitol, talc
• capsule shell (cap): titanium dioxide (E 171), gelatin, purified water, sodium lauryl sulfate, the 75 mg and 300 mg capsules also contain iron oxide red (E 172)
• capsule shell (body): titanium dioxide (E 171), gelatin, purified water, sodium lauryl sulfate
• Black Tek SW9008ink for printing: shellac, propylene glycol, iron oxide black (E 172), potassium hydroxide.

What Tabagine looks like and contents of the pack

Hard, gelatin capsules, size 4, with a red opaque cap and a white opaque body, and black ink printing with "rbx" on the cap and "PG75" on the body, containing a white to almost white powder. The length of the capsule is approximately 14.0 - 14.8 mm. 75 mg capsules Hard, gelatin capsules, size 2, with a white opaque cap and a white opaque body, and black ink printing with "rbx" on the cap and "PG150" on the body, containing a white to almost white powder. The length of the capsule is approximately 17.0 - 18.2 mm. 150 mg capsules Hard, gelatin capsules, size 0, with a red opaque cap and a white opaque body, and black ink printing with "rbx" on the cap and "PG300" on the body, containing a white to almost white powder. The length of the capsule is approximately 21.0 - 21.8 mm. 300 mg capsules Blisters of OPA/Aluminum/PCV//Aluminum, PCV//Al, or bottles of HDPE with a PP closure, with a child-resistant closure. Tabagine is available in packs of 14 and 56 capsules. Not all pack sizes may be marketed.

Marketing authorization holder

Ranbaxy (Poland) Sp. z o. o. ul. Idzikowskiego 16 00-710 Warsaw

Manufacturer/Importer

Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 2132JH Hoofddorp Netherlands Terapia S.A. Fabricii Street nr 124 400632 Cluj-Napoca, Jud. Cluj Romania Date of last revision of the leaflet:17.01.2024