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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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 disorder 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, 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:

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

Generalized anxiety disorder:

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

2. Important information before taking Tabagine

When not to take Tabagine:

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

Warnings and precautions

Before taking Tabagine, discuss it with your doctor or pharmacist.

• 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 rash. If any of these symptoms occur, 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 mentioned in section 4, stop taking pregabalin and seek medical attention immediately.
• Pregabalin has been associated with dizziness and somnolence: this may increase the risk of accidental injuries (falls) in the elderly. Therefore, caution should be exercised until the effects of the medicine are known.
• Taking pregabalin may cause blurred vision, loss of vision, or other vision disturbances, most of which are temporary. If you experience any changes in vision, inform your 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 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 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 disease. Before taking this medicine, inform your doctor if you have a history of heart disease.
• There have been reports of kidney failure in some patients taking pregabalin. If you notice a decrease in urine output while taking this medicine, inform your doctor, as stopping the medicine may cause the symptom to resolve.
• Some patients taking antiepileptic medicines such as pregabalin have had thoughts of self-harm or suicide. If you have ever had such thoughts or behaviors, contact your doctor immediately.
• If pregabalin is taken with other medicines that can cause constipation (such as some painkillers), gastrointestinal disturbances (such as constipation, obstruction, or paralysis of the intestines) may occur. Inform your doctor if you experience constipation, especially if you are prone to it.
• Before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription drugs, or street drugs, 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 you experience seizures, contact your doctor immediately.
• There have been reports of brain function impairment (encephalopathy) in some patients with other diseases. Inform your doctor about all serious diseases you have had, including liver or kidney disorders.

Inform your doctor about all serious diseases you have had, including liver or kidney disorders.

• There have been reports of breathing difficulties. If you have nervous system, respiratory, kidney, or other disorders, or if you are over 65 years old, your doctor may recommend a different dosing schedule. If you experience breathing difficulties or shallow breathing, contact your 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 you are concerned that you may become dependent on pregabalin, you must talk to your doctor. If you experience 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 prescribed
• Repeatedly trying 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 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 it safely.

Children and adolescents

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

Tabagine and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Tabagine and some medicines may interact with each other (interactions). Pregabalin taken with medicines that have a sedating effect (including opioids) may increase these effects, which can lead to respiratory failure, coma, and death. The degree of dizziness, drowsiness, 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. Do not drink alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

Tabagine should not be taken during pregnancy or breastfeeding, unless your doctor advises otherwise. Taking pregabalin during the first 3 months of pregnancy may cause birth defects in the unborn baby. In a study analyzing data from women in Scandinavian countries who took pregabalin during the first 3 months of pregnancy, 6 out of 100 babies had such birth defects. For comparison, in a study of 4 out of 100 babies born to women not taking pregabalin. Reports of malformations included facial defects, eye defects, nervous system defects (including brain defects), kidney defects, and genital defects. Women of childbearing age must use effective contraception. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Pregabalin may cause dizziness, drowsiness, and decreased concentration. Do not drive, operate complex machines, or perform potentially hazardous activities until you have determined how this medicine affects your 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 essentially 'sodium-free'. Mannitol may have a mild laxative effect.

3. How to take Tabagine

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 of the medicine. Your doctor will determine the dose that is right for you. The medicine is for oral use only.

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

• Take the number of capsules as prescribed by your doctor.
• The dose will generally be between 150 mg and 600 mg per day.
• Your doctor will tell you if you should take the medicine twice or three times a day. If you take it twice a day, take it in the morning and evening at the same time. If you take it three times a day, take it in the morning, at noon, and in the evening at the same time.

If you think the medicine is too strong or too weak, talk to your doctor or pharmacist. Patients over 65 years old should take the medicine as prescribed, unless they have kidney disease. In patients with impaired kidney function, the doctor may decide on a different dosing schedule and/or adjust the dose of the medicine. The capsule should be swallowed whole and washed down with water. Take the medicine for as long as your doctor prescribes it. The treatment can only be stopped on the doctor's advice.

Taking a higher dose of Tabagine than prescribed

Tell your doctor or go to the nearest hospital emergency department immediately. Take the medicine packaging with you. After taking a higher dose than prescribed, you may feel drowsy, confused, excited, or restless. Seizures have also been reported.

Missing a dose of Tabagine

It is important to take the medicine regularly at the same times every day. If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In this case, continue with the next dose as scheduled. Do not take a double dose to make up for a forgotten dose.

Stopping Tabagine treatment

Do not stop taking the medicine suddenly. If you want to stop taking the medicine, talk to your doctor first. Your doctor will tell you how to do it. If the treatment needs to be stopped, it should be done gradually over at least one week. Be aware that after stopping short-term or long-term pregabalin treatment, 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 you have taken Tabagine for a longer period. If you experience withdrawal symptoms, contact your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects:

If you experience any of the following, stop taking the medicine and contact your doctor or go to the nearest hospital immediately, as urgent medical attention may be needed.

• 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, and rash) (rare, may affect up to 1 in 1,000 people)
• Serious skin reaction characterized by red, flat, target-like, or circular 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 you experience swelling of the face or tongue, or if your skin turns red and blisters appear or the skin peels, 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, drowsiness, headache.

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 impairment, memory loss, tremors, speech disturbances, feeling of tingling, numbness, sedation, lethargy, insomnia, feeling of fatigue, feeling of abnormality;
• blurred vision, double vision;
• dizziness, balance disturbances, falls;
• dry mouth, constipation, vomiting, bloating, diarrhea, nausea, feeling of abdominal distension;
• erectile dysfunction;
• body swelling, including limb swelling;
• feeling of intoxication, ataxia;
• 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, nystagmus, uncontrolled movements of the limbs, decreased reflexes, increased activity, dizziness when standing up, skin hypersensitivity, loss of taste, burning sensation, tremor when moving, impaired consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise
• dry eyes, eye swelling, 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;
• sudden flushing of the skin of the face, sudden hot flushes;
• 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 twitching, joint swelling, muscle stiffness, pain, including muscle pain, neck pain;
• difficulty urinating, urinary incontinence;
• weakness, thirst, chest tightness;
• chest pain;
• painful menstruation;
• generalized swelling;
• 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):

• heart rhythm changes;
• changes in smell, sensation of rocking, changes in depth perception, bright vision, loss of vision;
• pupil dilation, strabismus;
• eye inflammation (keratitis);
• cold sweats, throat tightness, tongue swelling;
• difficulty swallowing;
• slow or limited movements;
• difficulty writing;
• fluid in the lungs;
• seizures;
• changes in ECG tracing corresponding to heart rhythm disturbances;
• ascites;
• muscle damage;
• spontaneous nipple 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 (decreased 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")

Be aware that after stopping short-term or long-term pregabalin treatment, side effects may occur, known as withdrawal symptoms (see section "Stopping Tabagine 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 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 you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, you can help provide more information on the safety of this medicine.

5. How to store Tabagine

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of that month. The batch number is stated after the batch number. There are no special precautions for storing the medicine. After the first opening of the bottle, the capsules should be used within 30 days. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tabagine contains

The active substance 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 red iron oxide (E 172)
• capsule shell (body): titanium dioxide (E 171), gelatin, purified water, sodium lauryl sulfate
• Black Tek SW-9008 ink for printing: shellac, propylene glycol, black iron oxide (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/PVC//Aluminum, PVC//Al, or HDPE bottles with 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