Tabagine

Package leaflet: Information for the user

Tabagine, 75 mg, hard capsules
Tabagine, 150 mg, hard capsules
Tabagine, 300 mg, hard capsules
Pregabalin
Please read the entire leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Tabagine is and what it is 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 Tabagine is and what it is used for

Tabagine belongs to a group of medicines used in the treatment of epilepsy, neuropathic pain, and generalised anxiety disorder in adults.

Peripheral and central neuropathic pain:
The medicine is used to treat long-term pain caused by nerve damage. Various conditions such as diabetes or shingles may cause peripheral neuropathic pain. Pain sensations may be described as burning, shooting, stabbing, tingling, aching, pulsating, electric shocks, cramps, pins and needles, or numbness. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, and fatigue, which may 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, with or without secondary generalisation). Your doctor may prescribe this medicine if your current treatment does not fully control your condition. Tabagine should always be added to your current therapy. This medicine should not be used as the sole treatment (monotherapy), but always in combination with other antiepileptic medicines.

Generalised anxiety disorder:
Tabagine is used for generalised anxiety disorder (GAD). Symptoms include prolonged, excessive anxiety and worry that are difficult to control. Generalised anxiety disorder may also cause motor restlessness, feeling keyed up or on edge, easy fatigue, difficulty concentrating or mind going blank, irritability, increased muscle tension, or sleep disturbances. These symptoms are distinct from the stresses and tensions of everyday life.

2. Important information before using Tabagine

When not to use 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, discuss this with your doctor or pharmacist.

• 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 widespread rash. If any of these symptoms occur, contact your doctor immediately.

• Serious skin reactions including severe forms of rash, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported with pregabalin. If the patient develops any symptoms of serious skin reactions listed in section 4, pregabalin must be discontinued and immediate medical help must be sought.

• Dizziness and drowsiness have been associated with pregabalin use: this may lead to an increased risk of accidental injuries (falls) in elderly patients. Therefore, caution should be exercised until the patient knows how the medicine affects them.

• Use of pregabalin may cause blurred vision, loss of vision, or other visual disturbances, most of which are temporary. If any changes in vision occur, inform your doctor immediately.

• In patients with diabetes, weight gain during treatment with pregabalin may necessitate adjustment of antidiabetic therapy.

• Some adverse effects such as drowsiness may occur more frequently, as patients with spinal cord injury may be taking other medications, e.g. painkillers or muscle relaxants, which have similar adverse effects to pregabalin, and the severity of these effects may be greater when such drugs are taken concomitantly.

• Cases of heart failure have been reported in some patients taking pregabalin; these were mainly elderly patients with cardiovascular disorders. Inform your doctor about any history of heart disease before starting this medicine.

• Cases of kidney failure have been reported in some patients taking pregabalin. If the patient notices a decrease in frequency of urination during treatment with this medicine, inform your doctor, as discontinuation of the drug may lead to resolution of this symptom.

• Some patients taking antiepileptic medicines such as pregabalin have had thoughts of self-harm or suicide. If such thoughts or behaviors occur at any time, contact your doctor immediately.

• If pregabalin is used concomitantly with other medicines that may cause constipation (such as certain painkillers), gastrointestinal disorders (e.g. constipation, bowel obstruction, or intestinal paralysis) may occur. Inform your doctor if the patient has constipation, especially if they are prone to it.

• Before starting treatment with this medicine, inform your doctor if the patient has ever misused or been dependent on alcohol, prescription medicines, or drugs, as this may indicate an increased risk of dependence on pregabalin.

• Seizures have been reported during treatment with pregabalin or shortly after discontinuation. If seizures occur, contact your doctor immediately.

• Cases of worsening brain function (encephalopathy) have been reported in some patients with other underlying diseases. Inform your doctor about all previous serious illnesses, including liver or kidney disorders.

• Cases of breathing difficulties have been reported. If the patient has neurological disorders, breathing problems, kidney dysfunction, or is over 65 years of age, the doctor may recommend an alternative dosing regimen. If the patient develops difficulty breathing or shallow breathing, contact your doctor.

Dependence
Some individuals may become dependent on pregabalin (need to continue taking the medicine). Withdrawal symptoms may occur after stopping pregabalin (see section 3 "How to take Tabagine" and "Stopping Tabagine").
If the patient is concerned about possibly becoming dependent on pregabalin, they should definitely discuss this with their doctor.
If the patient notices any of the following symptoms while taking pregabalin, this 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 recommended
• Taking the medicine for reasons other than those for which it was prescribed
• Repeated unsuccessful attempts to stop or control taking this medicine
• Feeling unwell after stopping the medicine and feeling better after taking it again

If the patient notices any of these symptoms, they should talk to their doctor to discuss the best treatment approach, including when to stop taking this medicine and how to do so safely.
Children and adolescents
The safety and efficacy have not been established in children and adolescents (under 18 years of age), therefore pregabalin should not be used in this age group.
Tabagine with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Tabagine and certain medicines may interact with each other. Pregabalin taken together with medicines that have a sedative effect (including opioids) may enhance these effects, potentially leading to respiratory failure, coma, and death. The severity of dizziness, drowsiness, and reduced concentration may increase if pregabalin is taken together with medicines containing:

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

Tabagine can be taken together with oral contraceptives.
Taking Tabagine with food, drink, and alcohol
Capsules may be taken with food or independently of meals. Alcohol should not be consumed during treatment with this medicine.
Pregnancy, breastfeeding, and fertility
Tabagine should not be used during pregnancy or breastfeeding unless otherwise advised by a doctor. Use of pregabalin during the first 3 months of pregnancy may cause congenital malformations in the unborn child requiring treatment. In a study analyzing data from women in Scandinavian countries who took pregabalin during the first 3 months of pregnancy, 6 out of every 100 children had such congenital malformations. For comparison, in a study of 4 out of every 100 children born to women not treated with pregabalin. Facial abnormalities (cleft lip/palate), eyes, nervous system (including brain), kidneys, and genital organs have been reported.
Women of childbearing age must use effective contraception.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Pregabalin may cause dizziness, drowsiness, and reduced concentration. Do not drive, operate complex machinery, or perform potentially dangerous activities until the effect of this medicine on the ability to perform these activities has been determined.
Tabagine contains sodium and mannitol
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, meaning 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 directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist. Do not take more medicine than prescribed.
Your doctor will determine the dose most appropriate for you.
This medicine is intended for oral use only.
Epilepsy, peripheral and central neuropathic pain, or generalized anxiety disorders:

• Take the number of capsules prescribed by your doctor.
• The dose appropriate for your condition will usually range from 150 mg to 600 mg per day.
• Your doctor will inform you whether Tabagine should be taken twice or three times daily. If taken twice daily, the medicine should be taken in the morning and evening at consistent times. If taken three times daily, the medicine should be taken in the morning, at midday, and in the evening at consistent times.

If you feel the medicine is too strong or not strong enough, you should inform your doctor or
pharmacist.
Patients over 65 years of age should take the medicine according to the recommended regimen unless
they have kidney disease.
In patients with impaired renal function, your doctor may decide on a different dosing regimen and/or
adjust the dose.
The capsule should be swallowed whole with water.
Continue taking the medicine for as long as your doctor recommends. Do not stop treatment without
your doctor's instruction.
Taking more Tabagine than recommended
Inform your doctor immediately or go to the nearest hospital emergency department without delay.
Take the medicine package with you. After taking more than the recommended dose, you may feel
drowsy, confused, agitated, or restless. Seizures have also been reported.
If you forget to take Tabagine
It is important to take the medicine regularly at the same times each day. If you miss a dose, take it as
soon as possible, unless it is almost time for your next dose. In that case, continue with your regular
dosing schedule. Do not take a double dose to make up for a missed capsule.
Stopping Tabagine treatment
Do not stop treatment suddenly. If you wish to discontinue taking Tabagine, you should first discuss this
with your doctor.
Your doctor will advise you on how to do this. If treatment needs to be stopped, it should be done
gradually over at least one week.
Be aware that withdrawal symptoms may occur after short- or long-term pregabalin treatment. These
are known as withdrawal symptoms and may 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 been taking Tabagine for a long time.
If withdrawal symptoms occur, contact your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions:
If any of the following reactions occur, stop taking the medicine and
contact a doctor immediately or go to the nearest hospital, as urgent medical assistance may be required.

• Hypersensitivity (uncommon, may affect up to 1 in 100 people) and allergic reactions (which may include facial swelling, tongue swelling, breathing difficulties, itching) (rare, may affect up to 1 in 1000 people)

• Severe skin reaction characterized by red, flat, disc-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital and eye lesions. Such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) (rare, may affect up to 1 in 1000 people). If facial or tongue swelling occurs, or if the skin turns red and blisters or peeling begin to appear, seek immediate medical advice.

• Pancreatitis (includes symptoms: severe pain in the upper part of the abdomen, often with nausea and
  vomiting) (rare, may affect up to 1 in 1000 people)
  Other adverse reactions:
  Very common adverse reactions (may affect more than 1 in 10 people):

• dizziness, drowsiness, headache.

Common adverse reactions (may affect less than 1 in 10 people):

• increased appetite;
• feeling of euphoria, confusion, disorientation, decreased sexual interest, irritability
• difficulty concentrating, clumsiness, memory disturbances, memory loss, tremors, speech difficulties, tingling sensation, numbness, sedation, lethargy, insomnia, feeling of fatigue, unusual feeling;
• blurred vision, double vision;
• dizziness, balance disorders, falls;
• dry mouth, constipation, vomiting, bloating, diarrhoea, nausea, feeling of abdominal distension;
• difficulty achieving erection;
• body swelling, including limbs;
• feeling of alcohol intoxication, abnormal gait;
• weight gain;
• muscle cramps, joint pain, back pain, limb pain, neck spasm;
• sore throat.

Uncommon adverse reactions (may affect less than 1 in 100 people):

• loss of appetite, weight loss, low blood sugar levels, high blood sugar levels;
• changes in self-perception, psychomotor agitation, depression, excitement, mood changes, difficulty finding the right words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychiatric disorders, difficulty thinking, increased sexual interest, sexual problems, including inability to achieve orgasm, delayed ejaculation;
• vision changes, unusual eye movements, visual disturbances, including tunnel vision, perception of flashes, sudden jerky movements, abnormal and uncontrolled limb movements, diminished reflexes, increased activity, dizziness upon standing, skin hypersensitivity, loss of taste, burning sensation, tremor during movement, disturbances of consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise;
• dry eyes, eye swelling, eye pain, weakened eye movement, tearing, eye irritation;
• heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure;
• sudden reddening of facial skin, sudden hot flushes;
• difficulty breathing, dry nose sensation, stuffy nose sensation;
• cough, facial swelling, urticaria, itching, catarrh, nosebleeds, snoring;
• increased salivation, heartburn, numbness around the mouth;
• sweating, rash, chills, fever;
• cold hands and feet;
• muscle tremors, joint swelling, muscle stiffness, pain, including muscle pain, neck pain;
• difficulty or painful urination, urinary incontinence;
• weakness, thirst, chest tightness;
• breast pain;
• painful menstruation;
• generalized edema;
• changes in blood test results and liver function (increased creatine phosphokinase, alanine aminotransferase and aspartate aminotransferase activity, decreased platelet count, decreased blood potassium levels, increased blood creatinine levels, neutropenia).

Rare adverse reactions (may affect less than 1 in 1000 people):

• changes in heart rhythm;
• altered sense of smell, sensation of image oscillation, altered depth perception, bright vision, vision loss;
• dilated pupils, strabismus;
• eye inflammation (keratitis);
• cold sweats, throat tightness, tongue swelling;
• difficulty swallowing;
• slowed or limited movements;
• difficulty with writing function;
• fluid in the lungs;
• seizures;
• ECG changes indicating disturbances in heart rhythm;
• ascites;
• muscle damage;
• nipple discharge, gynecomastia, breast enlargement in men;
• absence of menstruation;
• kidney failure, decreased urine volume, urinary retention;
• decreased white blood cell count;
• inappropriate behavior;
• jaundice (yellowing of the skin and whites of the eyes);
• Parkinsonism, i.e. symptoms resembling Parkinson's disease, such as tremor, bradykinesia (reduced movement ability), and rigidity (muscle stiffness).

Very rare (may affect less than 1 in 10,000 people):

• liver failure;
• hepatitis.

Frequency unknown: frequency cannot be determined from available data

• Dependence on pregabalin ("drug dependence")

It should be noted that after discontinuation of short- or long-term use of pregabalin, certain adverse reactions, known as withdrawal symptoms, may occur (see section "Discontinuing Tabagine").
Some adverse reactions, such as drowsiness, may occur more frequently because patients with spinal cord injury may be taking other medicines, e.g. painkillers or muscle relaxants, which have similar adverse reactions to Tabagine, and the severity of these reactions may be greater when such medicines are taken concomitantly.
Adverse reactions reported after marketing authorization: breathing difficulties, shallow breathing.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Tabagine

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and immediate packaging following the abbreviation: EXP. The expiry date refers to the last day of the stated month. The batch number is indicated after the abbreviation: Lot.
No special storage conditions are required for this medicine.
After first opening the bottle, the capsules should be used within 30 days.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Tabagine contains
The active substance is pregabalin. Each hard capsule contains 75 mg, 150 mg,
or 300 mg of pregabalin, respectively.
The excipients are:

• mannitol, talc
• capsule shell (cap): titanium dioxide (E 171), gelatin, purified water, sodium lauryl sulfate; capsules 75 mg and 300 mg also contain iron oxide red (E 172)
• capsule shell (body): titanium dioxide (E 171), gelatin, purified water, sodium lauryl sulfate
• printing ink Black Tek SW9008: 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 an opaque red cap, an opaque white body,
and printed in black ink with "rbx" on the cap and "PG75" on the body, containing
white to almost white powder. Capsule length is approximately 14.0 - 14.8 mm.
Hard gelatin capsules, size 2, with an opaque white cap, an opaque white body,
and printed in black ink with "rbx" on the cap and "PG150" on the body, containing
white to almost white powder. Capsule length is approximately 17.0 - 18.2 mm.
Hard gelatin capsules, size 0, with an opaque red cap, an opaque white body,
and printed in black ink with "rbx" on the cap and "PG300" on the body, containing
white to almost white powder. Capsule length is approximately 21.0 - 21.8 mm.
Blisters made of OPA/Aluminium/PVC//Aluminium, PVC//Al, or HDPE bottles with PP closure,
with child-resistant safety features.
Tabagine is available in pack sizes of 14 and 56 capsules.
Not all pack sizes may be marketed.

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

Manufacturer/Importer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands

Terapia S.A.
Fabricii Street no. 124
400632 Cluj-Napoca, Jud. Cluj
Romania