Pragiola

Package leaflet: Information for the patient

Pragiola, 25 mg, hard capsules
Pragiola, 50 mg, hard capsules
Pragiola, 75 mg, hard capsules
Pragiola, 100 mg, hard capsules
Pragiola, 150 mg, hard capsules
Pragiola, 200 mg, hard capsules
Pragiola, 225 mg, hard capsules
Pragiola, 300 mg, hard capsules
pregabalin
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Pragiola is and what it is used for

Pragiola belongs to a group of medicines used in the treatment of epilepsy, neuropathic pain, and generalized anxiety disorders in adults.

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

Epilepsy
Pragiola is used in the treatment of certain types of epilepsy (partial seizures, with or without secondary generalization). Your doctor may prescribe Pragiola if previous treatment has not fully controlled the disease. Pragiola should always be used as an add-on to current therapy. Pragiola should not be used as monotherapy, but always in combination with other antiepileptic medicines.

Generalized anxiety disorders
Pragiola is used in the treatment of generalized anxiety disorder (GAD). Symptoms of GAD include persistent, excessive anxiety and worry that are difficult to control. GAD may also cause 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 different from the stress and strain associated with everyday life.

2. Important information before using Pragiola

When not to use Pragiola

• 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 treatment with Pragiola, discuss this with your doctor or pharmacist.

• Some patients taking pregabalin have experienced symptoms indicating an allergic reaction. These symptoms include swelling of the face, lips, tongue, or throat, as well as widespread skin rash. If any of these symptoms occur, contact your doctor immediately.
• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin. If the patient develops any symptoms of severe skin reactions listed in section 4, pregabalin should 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.
• Treatment with Pragiola may cause blurred vision, vision loss, or other visual disturbances, most of which are transient. If any changes in vision occur, inform your doctor immediately.
• In diabetic patients who gain weight during pregabalin treatment, a change in antidiabetic therapy may be necessary.
• Certain adverse effects such as drowsiness may occur more frequently because patients with spinal cord injury may be taking other medications (e.g. painkillers or muscle relaxants) that have similar side effects to pregabalin, and the effects may be intensified 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. Before using this medicine, inform your doctor if you have ever had heart disease.
• Cases of kidney failure have been reported in some patients taking pregabalin. If the patient notices reduced frequency of urination while taking Pragiola, 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, or exhibited suicidal behaviour. If the patient ever experiences such thoughts or behaviours, contact your doctor immediately.
• If Pragiola 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 your doctor if the patient has constipation, especially if they are prone to it.
• Before starting this medicine, inform your doctor if the patient has ever abused or been dependent on alcohol, prescription medicines, or any illegal psychoactive substances; this may indicate an increased risk of dependence on pregabalin.
• Seizures have been reported during or shortly after discontinuation of pregabalin treatment. If seizures occur, contact your doctor immediately.
• Cases of worsening brain function (encephalopathy) have been reported in some patients with other underlying diseases who were taking pregabalin. Inform your doctor about all serious illnesses the patient has had, including liver or kidney disease.
• 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 Pragiola (a need to continue taking the medicine). Withdrawal symptoms may occur after stopping Pragiola (see section 3 "How to use Pragiola" and "Stopping Pragiola"). If the patient is concerned about possibly becoming dependent on Pragiola, they should definitely discuss this with their doctor.
If the patient notices any of the following symptoms while taking Pragiola, this may indicate dependence:

• Need to take the medicine for longer than prescribed by the doctor
• Feeling the need to take a higher dose than recommended
• Using the medicine for reasons other than those for which it was prescribed
• Repeated unsuccessful attempts to stop or control use of this medicine
• Feeling unwell after stopping the medicine and feeling better after restarting it

If the patient notices any of these symptoms, they should speak with 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 in children and adolescents (under 18 years of age) have not been established; therefore, pregabalin should not be used in this age group.

Pragiola and 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.
Pragiola and certain medicines may interact with each other. When taken together with other central nervous system depressants (e.g. opioids), Pragiola may enhance these effects and lead to respiratory depression, coma, and death. The degree of dizziness, drowsiness, and reduced concentration may increase if Pragiola is taken together with medicines containing:

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

Pragiola may be used together with oral contraceptives.

Taking Pragiola with food, drink and alcohol
Pragiola may be taken with or without food.
Alcohol should not be consumed while taking Pragiola.

Pregnancy, breastfeeding and fertility
Pragiola 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 country study analysing 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 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, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Pragiola 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 carry out these activities has been determined.

3. How to use Pragiola

This medicine should always be taken exactly as recommended by the doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist. Do not take a higher dose than prescribed.
Your doctor will determine the dose most appropriate for you.
Pragiola is intended for oral use only.
Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorders:

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

If you feel that Pragiola is too strong or not strong enough, inform your doctor or pharmacist.
Elderly patients (over 65 years of age) should take Pragiola as directed, unless kidney disease is present. In patients with impaired kidney function, the doctor may decide on a different dosing schedule and/or adjust the dose.
Swallow the capsules whole with water.
Continue taking Pragiola for as long as your doctor recommends. Do not discontinue treatment without medical advice.
Taking more Pragiola than recommended
Inform your doctor or go immediately to the nearest hospital emergency department. Bring the packaging of Pragiola with you.
After taking more than the recommended dose of Pragiola, you may experience drowsiness, confusion, agitation, or restlessness. Seizures and loss of consciousness (coma) have also been reported.
If you miss a dose of Pragiola
It is important to take Pragiola 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 dose.
Stopping Pragiola
Do not stop taking Pragiola suddenly. If you wish to discontinue Pragiola, speak to your doctor first. Your doctor will advise you on how to do this safely. If treatment needs to be stopped, it should be done gradually over at least one week.
Be aware that after short- or long-term treatment with Pragiola, certain unwanted effects, known as withdrawal symptoms, may occur. These symptoms include sleep disturbances, headache, nausea, feelings of 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 Pragiola 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If facial or tongue swelling occurs, or if redness of the skin appears accompanied by
blisters or skin peeling, medical advice must be sought immediately.

Very common adverse effects (may affect more than 1 in 10 patients)

• Dizziness, drowsiness, headache

Common adverse effects (may affect up to 1 in 10 patients)

• Increased appetite
• Euphoric mood, confusion, disorientation, decreased sexual interest, irritability
• Difficulty concentrating, clumsiness, memory disturbances, memory loss, tremor, speech difficulties, tingling sensation, numbness, sedation, lethargy, insomnia, feeling of fatigue, strange 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, unsteady gait
• Weight gain
• Muscle cramps, joint pain, back pain, limb pain
• Sore throat

Uncommon adverse effects (may affect up to 1 in 100 patients)

• Loss of appetite (anorexia), weight loss, low blood sugar, high blood sugar, changes in self-perception, psychomotor restlessness, depression, agitation, 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
• Visual disturbances, abnormal eye movements, visual disturbances including tunnel vision, perception of flashes, jerky movements, reduced 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, weakness of eye movements, tearing, eye irritation
• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
• Sudden reddening of the facial skin, sudden hot flushes
• Breathing difficulties, dryness in the nose, sensation of blocked nose
• Increased salivation, heartburn, tingling sensation around the mouth
• Sweating, rash, chills, fever
• Muscle tremors, joint swelling, muscle stiffness, pain including muscle pain, neck pain
• Chest pain
• Difficulty urinating or painful urge to urinate, urinary incontinence
• Weakness, thirst, chest tightness
• Changes in blood test results and liver function (increased creatine phosphokinase, alanine aminotransferase and aspartate aminotransferase activity, decreased platelet count, neutropenia, increased blood creatinine concentration, decreased blood potassium concentration)
• Hypersensitivity, facial swelling, itching, urticaria, catarrh, nosebleeds, cough, snoring
• Painful menstruation
• Cold hands and feet

Rare adverse effects (may affect up to 1 in 1,000 patients)

• Altered sense of smell, sensation of image oscillation, altered depth perception, vivid vision, vision loss
• Dilated pupils, strabismus
• Cold sweats, throat tightness, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slowed or limited movements
• Difficulty with writing function
• Ascites
• Fluid in the lungs
• Seizures
• Changes in ECG recording (changes in electrical heart activity) corresponding to heart rhythm disturbances
• Muscle damage
• Nipple discharge, breast enlargement, gynecomastia in males
• Absence of menstruation
• Kidney failure, reduced volume of urine output, urinary retention
• Decreased white blood cell count
• Inappropriate behaviour, suicidal behaviour, suicidal thoughts
• Allergic reactions, which may include breathing difficulties, eye inflammation (keratitis), and a serious skin reaction characterised by red, flat, disc-shaped or round spots on the trunk, often with blisters in their centre, skin peeling, oral, throat, nose, genital or eye mucosal ulcers. 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 eyes)
• Parkinsonism, i.e. symptoms resembling Parkinson's disease, such as tremor, bradykinesia (reduced ability to move) and rigidity (muscle stiffness)

Very rare adverse effects (may affect up to 1 in 10,000 patients)

• Liver failure
• Hepatitis

Frequency not known: frequency cannot be estimated from available data

• Dependence on Pragiola (‘drug dependence’). It should be noted that after discontinuation of short- or long-term use of Pragiola, certain adverse effects may occur, known as withdrawal symptoms (see section “Stopping treatment with Pragiola”).

Some adverse 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 adverse effects to Pragiola, and the severity of these effects may be greater when such medicines are taken concomitantly.
Since the medicine was placed on the market, the following adverse effects have been reported: breathing difficulties, shallow breathing.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, tell your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Pragiola medicine

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging following the abbreviation "Lot".
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What the medicine contains

• The active substance is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin, respectively.
• Other ingredients: capsule contents: maize starch, pregelatinised starch, talc; 25 mg, hard capsule capsule shell: titanium dioxide (E 171), gelatin, black ink [shellac, iron oxide black (E 172), propylene glycol]; 50 mg, 75 mg, hard capsule capsule shell: titanium dioxide (E 171), gelatin, iron oxide yellow (E 172), black ink [shellac, iron oxide black (E 172), propylene glycol]; 100 mg, hard capsule capsule shell: titanium dioxide (E 171), gelatin, iron oxide red (E 172), white ink [shellac, propylene glycol, potassium hydroxide, titanium dioxide (E 171)]; 150 mg, hard capsule capsule shell: titanium dioxide (E 171), gelatin, iron oxide red (E 172), iron oxide yellow (E 172), black ink [shellac, iron oxide black (E 172), propylene glycol]; 200 mg, 225 mg, hard capsule capsule shell: titanium dioxide (E 171), gelatin, iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172), black ink [shellac, iron oxide black (E 172), propylene glycol]; 300 mg, hard capsule capsule shell: titanium dioxide (E 171), gelatin, iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172), white ink [shellac, propylene glycol, potassium hydroxide, titanium dioxide (E 171)]

What Pragiola looks like and contents of the pack
25 mg, hard capsules: white capsule with black marking "P25" on the cap;
the capsule contains white to off-white powder; capsule length: 13.8–14.8 mm
50 mg, hard capsules: body of the capsule is white, cap is light yellow; black marking "P50" on the cap;
the capsule contains white to off-white powder; capsule length: 15.3–16.2 mm
75 mg, hard capsules: yellowish-brown capsule with black marking "P75" on the cap;
the capsule contains white to off-white powder; capsule length: 13.8–14.8 mm
100 mg, hard capsules: reddish-brown capsule with white marking "P100" on the cap;
the capsule contains white to off-white powder; capsule length: 15.3–16.2 mm
150 mg, hard capsules: body of the capsule is white, cap is yellowish-brown; black marking "P150" on the cap;
the capsule contains white to off-white powder; capsule length: 17.2–18.3 mm
200 mg, hard capsules: brown capsule with black marking "P200" on the cap;
the capsule contains white to off-white powder; capsule length: 18.7–19.8 mm
225 mg, hard capsules: body of the capsule is white, cap is brown; black marking "P225" on the cap;
the capsule contains white to off-white powder; capsule length: 18.7–19.8 mm
300 mg, hard capsules: body of the capsule is white, cap is dark brown; white marking "P300" on the cap;
the capsule contains white to off-white powder; capsule length: 20.0–22.1 mm

Pack sizes:
Pragiola 25 mg, 50 mg, 100 mg, 200 mg, 225 mg, 300 mg, hard capsules:
14, 28, 30, 56, 60, 84, 90 or 100 hard capsules in a cardboard box.
Pragiola 75 mg, 150 mg, hard capsules:
14, 28, 30, 56, 60, 84, 90, 98 or 100 hard capsules in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer/Importer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For more detailed information on the names of the medicinal products in other European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Tel. 22 57 37 500