Pentegin

Patient Information Leaflet

Pentegin, 75 mg, hard capsules
Pentegin, 150 mg, hard capsules
Pentegin, 300 mg, hard capsules
Pregabalinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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, tell your doctor or pharmacist. See section 4.

Table of contents

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

1. What Pentegin is and what it is used for

Pentegin belongs to a group of medicines used in the treatment of epilepsy, neuropathic pain, and generalized anxiety disorders in adults (in English: Generalised Anxiety Disorder – GAD).

Peripheral and central neuropathic pain:
Pentegin is used to treat long-term pain caused by nerve damage. Various medical conditions such as diabetes or shingles may cause peripheral neuropathic pain. Pain sensations may be described as feelings of heat, burning, pulsing, shooting, stabbing, sharp pain, cramps, aching, tingling, or numbness. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue, which may affect the patient's physical and social functioning and overall quality of life.

Epilepsy:
Pentegin is used in the treatment of certain types of epilepsy (partial seizures, with or without secondary generalization) in adults. Your doctor may prescribe Pentegin if your current treatment does not fully control your condition. Pentegin should always be used as an add-on therapy to your current antiepileptic treatment. Pentegin must not be used as monotherapy, but always in combination with other antiepileptic medicines.

Generalized anxiety disorder:
Pentegin is used in the treatment of generalized anxiety disorder (in English: Generalised Anxiety Disorder – GAD). Symptoms of GAD include persistent, excessive anxiety and worry that are difficult to control. GAD may also cause motor restlessness, nervousness or a feeling of being keyed up, easy fatigue, difficulty concentrating or a sensation of "mind going blank", irritability, increased muscle tension, or sleep disturbances. These symptoms are different from the everyday stresses and strains of normal life.

2. Information before taking Pentegin

• When not to take Pentegin
  Do not take Pentegin 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 Pentegin, discuss this with your doctor or pharmacist.

• Some patients taking Pentegin have experienced symptoms suggesting an allergic reaction. These symptoms included swelling of the face, lips, tongue, and throat, as well as widespread skin rash. If any of these symptoms occur, contact a doctor immediately.
• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin. If the patient experiences any symptoms of severe skin reactions listed in section 4, treatment with pregabalin must be stopped immediately and medical help must be sought without delay.
• Pentegin may cause dizziness and drowsiness, which may lead to an increased risk of accidental injuries (e.g. falls) in elderly patients. Therefore, caution should be exercised until the effects of the medicine are known.
• Pentegin may cause blurred vision, loss of vision, or other visual disturbances, most of which are transient. If any changes in vision occur, inform the doctor immediately.
• In diabetic patients, weight gain during pregabalin treatment may necessitate adjustment of antidiabetic therapy.
• Certain side effects, such as drowsiness, may occur more frequently because patients with spinal cord injury may also be taking other medications (e.g. analgesics or muscle relaxants) that have similar side effects to Pentegin, and the combined effect may be greater when these medicines are taken together.
• Cases of heart failure have been reported in some patients taking Pentegin; these were mainly elderly patients with cardiovascular disorders. Before taking this medicine, inform the doctor if the patient has a history of heart disease.
• Cases of kidney failure have been reported in some patients taking Pentegin. If the patient notices reduced frequency of urination while taking Pentegin, inform the doctor immediately, as discontinuation of the drug may lead to resolution of this symptom.
• A small number of patients taking antiepileptic medicines such as Pentegin have had thoughts of self-harm or suicide, or exhibited suicidal behavior. If such thoughts or behaviors occur at any time, contact the doctor immediately.
• If Pentegin is taken together with other medicines that may cause constipation (such as certain painkillers), gastrointestinal problems (e.g. constipation, bowel obstruction, or intestinal paralysis) may occur. Inform the doctor if the patient experiences constipation, especially if there is a predisposition to it.
• Before starting this medicine, inform the doctor if the patient has ever abused or been dependent on alcohol, prescription medicines, or any illegal psychoactive substances, as this may indicate an increased risk of dependence on Pentegin.
• Seizures have been reported during treatment with Pentegin or shortly after stopping treatment. If seizures occur, contact the doctor immediately.
• Cases of worsening brain function (encephalopathy) have been reported in some patients with other underlying diseases who were taking Pentegin. Inform the doctor about all previous serious illnesses, including liver or kidney disease.
• Cases of breathing difficulties have been reported. If the patient has neurological disorders, respiratory disorders, kidney impairment, or is over 65 years of age, the doctor may recommend an alternative dosing regimen. If the patient experiences difficulty breathing or shallow breathing, contact the doctor immediately.

Dependence
Some individuals may become dependent on Pentegin (a need to continue taking the medicine).
Withdrawal symptoms may occur after stopping Pentegin (see section 3 "How to take Pentegin" and "Stopping Pentegin"). If the patient is concerned about possible dependence on Pentegin, they should discuss this with their doctor.
If the patient notices any of the following symptoms while taking Pentegin, this may indicate dependence:

• Needing 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 the medicine
• Feeling unwell after stopping the medicine and feeling better after restarting it

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

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

Pentegin with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Pentegin and certain medicines may interact with each other. Taking Pentegin together with other central nervous system depressants (including opioids) may increase the side effects of these medicines and may lead to respiratory depression, coma, and death. The severity of dizziness, drowsiness, and reduced concentration may increase if Pentegin is taken together with medicines containing:

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

Pentegin may be taken together with oral contraceptives.

Pentegin with food, drink, and alcohol
Pentegin capsules may be taken with or without food.
Alcohol should not be consumed during treatment with Pentegin.

Pregnancy and breastfeeding
Pentegin should not be used during pregnancy or breastfeeding unless otherwise decided by the doctor. Use of pregabalin during the first three months of pregnancy may cause congenital malformations in the unborn child requiring treatment.
A Scandinavian study analyzing data from women who took pregabalin during the first three months of pregnancy showed congenital malformations in 6 out of every 100 live births, compared to 4 out of every 100 live births in women who were not treated with pregabalin. Reported congenital malformations involved the face (cleft lip and palate), eyes, nervous system (including the brain), kidneys, and genital organs.
Women of childbearing potential should use an effective method of contraception.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.

Driving and using machines
Pentegin 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 such tasks has been determined.

Pentegin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Pentegin

This medicine should always be taken as directed by the physician. In case of doubts, consult
your doctor or pharmacist. Do not take a higher dose than prescribed.
The doctor will determine the dose most suitable for the individual patient.
Pentegin is intended for oral use only.
Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorders:

• Take the number of capsules recommended by your doctor.
• The recommended dose will range from 150 mg to 600 mg per day.
• Your treating physician will inform you whether Pentegin should be taken twice or three times daily. If taken twice daily, Pentegin should be taken in the morning and evening at the same time each day. If taken three times daily, Pentegin should be taken once in the morning, once at midday, and once in the evening, always at the same time each day.

If you feel that Pentegin is too strong or not strong enough, inform your doctor or pharmacist.
Patients over 65 years of age should take Pentegin as directed, unless kidney disease is present.
For patients with impaired renal function, the doctor may decide on a different dosing schedule and/or adjust the dose.
The capsule should be swallowed whole with water.
Pentegin should be taken for as long as your doctor recommends. Treatment must only be discontinued on the advice of your doctor.
Taking more Pentegin than prescribed
Inform your doctor or go immediately to the nearest hospital emergency department. Bring the Pentegin packaging with you. After taking more than the prescribed dose of Pentegin, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.
Missing a dose of Pentegin
It is important to take Pentegin 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 treatment according to the prescribed schedule. Do not take a double dose to make up for a missed dose.
Stopping Pentegin
Do not stop taking Pentegin suddenly. If you wish to discontinue Pentegin, speak to your doctor first. 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 after stopping short- or long-term treatment with Pentegin, certain adverse effects, known as withdrawal symptoms, may occur. These symptoms include sleep disturbances, headache, nausea, anxiety, diarrhoea, 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 been taking Pentegin 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 side effects

Like all medicines, this one may cause side effects, although not everyone experiences 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
• Euphoria, confusion, disorientation, decreased sexual interest, irritability
• Difficulty concentrating, clumsiness, memory disturbances, memory loss, tremor, speech difficulties, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, unusual feeling
• Blurred vision, double vision
• Dizziness (spinning sensation), balance disorders, falls
• Dry mouth, constipation, vomiting, bloating, diarrhoea, nausea, abdominal distension
• Difficulty achieving erection
• Body swelling, including limbs
• Feeling of alcohol intoxication, unsteady gait
• Weight gain
• Muscle cramps, joint pain, back pain, limb pain
• Sore throat

Uncommon – may affect up to 1 in 100 people:

• Loss of appetite, weight loss, low blood sugar, high blood sugar
• Changes in self-perception, psychomotor agitation, depression, restlessness, mood changes, difficulty finding words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychiatric disturbances, difficulty thinking, increased sexual interest, sexual problems including inability to achieve orgasm, delayed ejaculation
• Vision changes, abnormal eye movements, visual disturbances including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness when standing, skin hypersensitivity, loss of taste, burning sensation, action tremor, decreased level of consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise
• Dry eyes, eye swelling, eye pain, reduced eye movement, tearing, eye irritation
• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
• Sudden facial redness, hot flushes
• Breathing difficulties, dry nose, stuffy nose
• Increased salivation, heartburn, numbness around the mouth
• Sweating, rash, chills, fever
• Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain
• Chest pain
• Urination difficulties or painful urge to urinate, urinary incontinence
• Weakness, thirst, chest tightness
• Changes in blood test results and liver function (increased creatine kinase, alanine aminotransferase, and aspartate aminotransferase activity, decreased platelet count, neutropenia, increased blood creatinine, decreased blood potassium)
• Hypersensitivity, facial swelling, itching, urticaria, rhinitis, nosebleeds, cough, snoring
• Painful menstruation
• Cold hands and feet

Rare – may affect up to 1 in 1,000 people:

• Altered sense of smell, sensation of image oscillation, altered depth perception, bright vision, vision loss
• Dilated pupils, strabismus
• Cold sweats, throat tightness, tongue swelling
• Pancreatitis
• Swallowing difficulties
• Slowed or limited movements
• Writing difficulties
• Ascites
• Fluid in the lungs
• Seizures
• ECG changes indicating heart rhythm disturbances
• Muscle damage
• Nipple discharge, breast enlargement, gynaecomastia in men
• Absence of menstruation
• Kidney failure, reduced urine output, urinary retention
• Decreased white blood cell count
• Abnormal behaviour, suicidal behaviour, suicidal thoughts
• Allergic reactions, which may include breathing difficulties, eye inflammation (keratitis), and severe skin reaction characterized by red, flat, disc-shaped or round spots on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. Such serious 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 resembling Parkinson's disease, such as tremor, bradykinesia (reduced movement), and rigidity (muscle stiffness)

Very rare – may affect up to 1 in 10,000 people:

• Liver failure
• Hepatitis

Frequency not known: frequency cannot be estimated from available data

• Dependence on Pentegin ("drug dependence")

Be aware that after stopping short- or long-term use of Pentegin, certain adverse effects, known as withdrawal symptoms, may occur (see section "Stopping Pentegin").
If facial or tongue swelling occurs, or if skin redness with blisters or skin peeling develops, seek immediate medical advice.
Some side effects, 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 side effects to Pentegin, and these effects may be intensified when such medicines are taken together.
Following the introduction of pregabalin into the market, the following adverse reaction has also been reported: breathing difficulties, shallow breathing.
If any side effects occur, contact your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Reporting side effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Pentegin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister pack following: EXP. The expiry date refers to the last day of the specified month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Pentegin contains
The active substance is pregabalin. Each hard capsule contains 75 mg, 150 mg, or 300 mg of pregabalin.
The other ingredients are: corn starch, pregelatinized corn starch, talc, gelatin, titanium dioxide (E171), sodium lauryl sulfate, black ink (containing shellac, iron oxide black (E172), propylene glycol, potassium hydroxide) and purified water.
The 75 mg and 300 mg capsules also contain iron oxide red (E172).

Pentegin is available in seven pack sizes made of aluminium/PVC/PVdC foil: 14 capsules, 21 capsules, 56 capsules, 70 capsules, 84 capsules, 100 capsules and 112 capsules, in a cardboard box.
Additionally, Pentegin is available in a HDPE container with a HDPE child-resistant closure and induction seal, containing 30 hard capsules, and in a HDPE container with a HDPE closure and induction seal, containing 100 hard capsules, in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Egis Pharmaceuticals PLC
Keresztúri út 30-38.
1106 Budapest
Hungary
Importer
Torrent Pharma (Malta) Ltd.
HHF 028, Hal Far Industrial Estate,
Birzebbuga BBG3000
Malta
GE Pharmaceuticals Ltd.
Industrial Zone, Chekanitza South Area,
2140 Botevgrad, Bulgaria
This medicinal product is authorised for marketing in the Member States of the European Economic Area under the following names:
Czech Republic Pentegin 75 mg tvrdé tobolky
Pentegin 150 mg tvrdé tobolky
Pentegin 300 mg tvrdé tobolky
Poland Pentegin
Slovakia Pentegin 75 mg tvrdé kapsuly,
Pentegin 150 mg tvrdé kapsuly
Pentegin 300 mg tvrdé kapsuly
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00