Preato

Patient Information Leaflet

Preato 25 mg tablets
Preato 50 mg tablets
Preato 75 mg tablets
Preato 100 mg tablets
Preato 150 mg tablets
Preato 200 mg tablets
Preato 225 mg tablets
Preato 300 mg tablets
Pregabalin
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• 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 Preato is and what it is used for
2. What you need to know before taking Preato
3. How to take Preato
4. Possible side effects
5. How to store Preato
6. Contents of the pack and other information

1. What Preato is and what it is used for

Preato 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: Preato is used to treat long-term pain caused by nerve damage. Various diseases such as diabetes or shingles may cause peripheral neuropathic pain. Pain sensations may be described as burning, shooting, pulsing, 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: Preato is used in the treatment of certain types of epilepsy (partial seizures, with or without secondary generalization) in adults. Your doctor may prescribe Preato if previous treatment has not fully controlled the disease. Preato should always be used as an add-on therapy to current treatment. Preato should not be used as monotherapy but always in combination with other antiepileptic drugs.

Generalized anxiety disorder (GAD): Preato 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 motor restlessness, nervousness or feeling keyed up, easy fatigue, difficulty concentrating or a feeling of "mind going blank", irritability, increased muscle tension, or sleep disturbances. These symptoms are different from the stresses and tensions associated with everyday life.

2. What you need to know before taking Preato

Do not take Preato if:

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

Warnings and precautions

Before starting Preato, discuss this with your doctor or pharmacist.

• Some patients taking Preato have experienced symptoms suggesting 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 you experience any of the serious skin reactions listed in section 4, stop taking pregabalin and seek immediate medical attention.
• Dizziness and drowsiness have been reported with Preato use: this may increase the risk of accidental injury (falls) in elderly patients. Therefore, exercise caution until you know how this medicine affects you.
• Preato may cause blurred vision, loss of vision, or other visual disturbances, most of which are temporary. If you experience any changes in vision, inform your doctor immediately.
• In diabetic patients, weight gain during pregabalin treatment may necessitate adjustment of antidiabetic therapy.
• 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 Preato, and the effects may be intensified when such medicines are taken together.
• Cases of heart failure have been reported in some patients taking Preato, primarily in elderly patients with cardiovascular disorders. Before taking this medicine, inform your doctor if you have a history of heart disease.
• Cases of kidney failure have been reported in some patients taking Preato. If you notice a decrease in the frequency of urination while taking Preato, inform your doctor, as discontinuation of the medicine may resolve this symptom.
• A small number of patients taking antiepileptic medicines such as Preato have had thoughts of self-harm or suicide, or exhibited suicidal behavior. If you experience such thoughts or behaviors, contact your doctor immediately.
• If Preato 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 you have constipation, especially if you are prone to it.
• Before starting this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or any illegal psychoactive substances; this may mean you have an increased risk of becoming dependent on Preato.
• Seizures have been reported during Preato treatment or shortly after stopping 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 Preato. Inform your doctor about all serious illnesses you have had, including liver or kidney disease.
• Cases of breathing difficulties have been reported. If you have neurological disorders, breathing problems, kidney problems, or are over 65 years of age, your doctor may recommend a different dosing regimen. If you experience difficulty breathing or shallow breathing, contact your doctor.

Dependence

Some people may become dependent on Preato (a need to continue taking the medicine). Withdrawal symptoms may occur when stopping Preato (see section 3 "How to take Preato" and "Stopping Preato"). If you are concerned that you may become dependent on Preato, you should discuss this with your doctor.

If you notice any of the following symptoms while taking Preato, this may indicate dependence:

• Needing to take the medicine for a longer period than prescribed by your 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 restarting it

If you notice any of these symptoms, talk to your doctor to discuss the best treatment approach, including when and how to stop taking this medicine safely.

Children and adolescents

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

Preato with other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Preato and certain other medicines may interact with each other.

Taking Preato together with other medicines that have a sedative effect (including opioids) may increase these effects and lead to respiratory depression, coma, and death.

The severity of dizziness, drowsiness, and reduced concentration may increase if Preato is taken together with medicines containing:

• Oxycodone – (a painkiller)
• Lorazepam – (a medicine used for anxiety)
• Alcohol

Preato may be taken together with oral contraceptives.

Preato with food, drink, and alcohol

Preato tablets may be taken with or without food.

It is recommended not to drink alcohol while taking Preato.

Pregnancy and breastfeeding

Preato should not be used during pregnancy or breastfeeding unless otherwise directed by your doctor. Taking pregabalin during the first three months of pregnancy may cause congenital malformations in the unborn child that require treatment. A study conducted in Scandinavian countries 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 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 you are pregnant or breastfeeding, suspect you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Preato may cause dizziness, drowsiness, and reduced concentration. Do not drive, operate complex machinery, or perform potentially dangerous activities until you know how this medicine affects your ability to perform these tasks.

3. How to take Preato

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

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

If the patient feels that Preato is too strong or not strong enough, they should inform their doctor or
pharmacist.
Patients over 65 years of age should take Preato as directed, 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.
The tablet should be swallowed whole with water.
Preato should be taken for as long as directed by the doctor. Treatment should only be stopped on
the doctor's advice.
Taking more Preato than prescribed
Inform your doctor or go immediately to the nearest hospital emergency department. Bring the
medicine packaging with you. After taking more than the prescribed dose of Preato, the patient may
feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also
been reported.
Missing a dose of Preato
It is important to take Preato tablets regularly at the same times each day. If a dose is missed, take
it as soon as possible, unless it is almost time for the next dose. In that case, continue with the
regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Preato
Do not stop taking Preato suddenly. If the patient wishes to stop taking Preato, they should first
discuss this with their doctor. The doctor will advise on how to do this. If treatment needs to be
stopped, it should be done gradually over at least one week. It should be known that after stopping
short- or long-term treatment with Preato, certain withdrawal symptoms may occur. These 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 the patient has been taking Preato 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 gets them.
Very common - may occur in more than 1 in 10 people:
Dizziness, somnolence, headache
Common - may occur in up to 1 in 10 people:

• Increased appetite

• Euphoria, confusion, disorientation, decreased libido, irritability

• Difficulty concentrating, clumsiness, memory disturbances, amnesia, tremor, speech difficulties, tingling sensation, numbness, sedation, lethargy, insomnia, feeling of fatigue,
  strange feeling

• Blurred vision, double vision

• Dizziness, balance disorders, fall

• Dry mouth, constipation, vomiting, bloating, diarrhoea, nausea, feeling of abdominal distension

• Difficulty achieving erection

• Swelling of the body, including limbs

• Feeling of alcohol intoxication, abnormal gait

• Weight gain

• Muscle cramps, joint pain, back pain, limb pain

• Sore throat

Uncommon - may occur in 1 in 100 people:

• Loss of appetite, weight loss, low blood sugar levels, high blood sugar levels
• Changes in self-perception, psychomotor agitation, depression, restlessness, 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, abnormal eye movements, visual disturbances including tunnel vision, perception of flashes of light, 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 disorders, 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, blocked nose sensation
• Increased salivation, heartburn, tingling sensation around the mouth
• Sweating, rash, chills, fever
• Muscle tremors, joint swelling, muscle stiffness, pain including muscle pain, neck pain
• Breast 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 - may occur in 1 in 1,000 people:

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

Very rare - may occur in 1 in 10,000 people:

• Liver failure
• Hepatitis

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

• Dependence on Preato medicine ("drug dependence")

It should be noted that after discontinuation of short- or long-term pregabalin use, certain adverse effects may occur, known as withdrawal symptoms (see section "Discontinuing treatment with Preato").
If facial or tongue swelling occurs, or if skin redness appears accompanied by blisters or skin peeling, seek immediate medical advice.
Some adverse effects, such as somnolence, may occur more frequently because patients with spinal cord injury may be taking other medicines, e.g. analgesics or muscle relaxants, which have similar adverse effects to Preato, and the severity of these effects may be greater when such medicines are taken concomitantly.
After 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 not listed in this leaflet, inform your doctor or pharmacist. 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,
Tel.: + 48 22 49 21 301
Faks: + 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 provide more information on the safety of the medicine.

5. How to store the medicine Preato

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging following:
EXP. The expiry date refers to the last day of the specified month.
The batch number is indicated on the label and packaging following the abbreviation (Lot).
No special storage conditions are required for this medicine.
Medicines must 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 Preato contains
The active substance is pregabalin.
Preato 25 mg tablets
Each tablet contains 25 mg of pregabalin.
Preato 50 mg tablets
Each tablet contains 50 mg of pregabalin.
Preato 75 mg tablets
Each tablet contains 75 mg of pregabalin.
Preato 100 mg tablets
Each tablet contains 100 mg of pregabalin.
Preato 150 mg tablets
Each tablet contains 150 mg of pregabalin.
Preato 200 mg tablets
Each tablet contains 200 mg of pregabalin.
Preato 225 mg tablets
Each tablet contains 225 mg of pregabalin.
Preato 300 mg tablets
Each tablet contains 300 mg of pregabalin.
The other ingredients are: microcrystalline cellulose, magnesium stearate.

What Preato looks like and contents of the pack
25 mg tablets: Round, biconvex tablets with an embossed mark “I” on one side, 5 mm in diameter.
50 mg tablets: Round, biconvex tablets with an embossed mark “M1” on one side, 7 mm in diameter.
75 mg tablets: Round, biconvex tablets with an embossed mark “I1” on one side, 8 mm in diameter.
100 mg tablets: Round, biconvex tablets with an embossed mark “M2” on one side, 9 mm in diameter.
150 mg tablets: Round, biconvex tablets with an embossed mark “I2” on one side, 10 mm in diameter.
200 mg tablets: Round, biconvex tablets with an embossed mark “M3” on one side, 12 mm in diameter.
225 mg tablets: Round, biconvex tablets with an embossed mark “M7” on one side, 12 mm in diameter.
300 mg tablets: Elongated, biconvex tablets with an embossed mark "I3" on one side, 20 mm in length and 8 mm in width.

The pack contains PA/Aluminum/PVC/Aluminum foil blisters containing 14, 28, 56, or 84 tablets.

Marketing Authorisation Holder
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld
Germany

Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí (Barcelona)
Spain