Preato

Leaflet accompanying the packaging: information for the user

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Preato and what is it used for
• 2. Important information 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 is Preato and what is it used for

Preato 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: Preato 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: Preato is used to treat certain types of epilepsy (partial seizures, which may or may not be secondary generalized) in adults. The doctor may prescribe Preato if the current treatment does not fully control the course of the disease. Preato should always be used as an add-on therapy to the currently used treatment. Preato should not be used as monotherapy, but always in combination with other antiepileptic drugs.
Generalized anxiety disorder:Preato is used to treat generalized anxiety disorder (GAD). GAD symptoms include prolonged excessive anxiety and worry that is difficult to control. GAD can also cause restlessness, feeling on edge or irritability, easily becoming fatigued, difficulty concentrating or feeling empty in the head, irritability, increased muscle tension, or sleep disturbances. The symptoms are different from the stresses and strains of everyday life.

2. Important information before taking Preato

When not to take Preato:

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 Preato, the patient should discuss it with their doctor or pharmacist.

• In some patients taking Preato, symptoms suggesting an allergic reaction have been reported. These symptoms included swelling of the face, lips, tongue, and throat, as well as a widespread rash. If any of these symptoms occur, the patient should contact their doctor immediately.
• Pregabalin has been associated with severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. If the patient experiences any of the serious skin reactions listed in section 4, they should stop taking pregabalin and seek medical attention immediately.
• Taking Preato has been associated with dizziness and somnolence: this may increase the risk of accidental injury (falls) in the elderly. Therefore, caution should be exercised until the patient is aware of the possible effects of the medicine.
• Taking Preato may cause blurred vision, loss of vision, or other vision disturbances, most of which are temporary. If any changes in vision occur, the patient should inform their 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 somnolence, 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 severity of these effects may be greater when such medicines are taken concomitantly.
• There have been reports of heart failure in some patients taking Preato; these were mainly elderly patients with cardiovascular disease. Before taking this medicine, the patient should tell their doctor if they have a history of heart disease.
• There have been reports of kidney failure in some patients taking Preato. If the patient notices a decrease in urine output while taking Preato, they should inform their doctor, as stopping the medicine may cause the symptom to resolve.
• A small number of patients taking antiepileptic drugs, such as Preato, have had thoughts of self-harm or suicide, or have exhibited suicidal behavior. If the patient has ever had such thoughts or behavior, they should contact their doctor immediately.

and seek medical attention.

• If Preato is taken with other medicines that can cause constipation (such as some painkillers), gastrointestinal problems (e.g., constipation, obstruction, or paralysis of the intestines) may occur. The patient should inform their doctor if they experience constipation, especially if they are prone to it.
• Before starting to take this medicine, the patient should tell their doctor if they have ever abused or been dependent on alcohol, prescription drugs, or any illegal psychoactive substances; this may indicate that they are at increased risk of dependence on Preato.
• There have been reports of seizures during treatment with Preato or shortly after stopping treatment. If seizures occur, the patient should contact their doctor immediately.
• There have been reports of brain function impairment (encephalopathy) in some patients with other diseases who took Preato. The patient should inform their doctor about all serious diseases they have had, including liver or kidney disease.
• There have been reports of breathing difficulties. If the patient has nervous system disorders, respiratory disorders, kidney function disorders, or is over 65 years old, the doctor may recommend a different dosing schedule. If the patient experiences breathing difficulties or shallow breathing, they should contact their doctor.

Dependence
Some people may become dependent on Preato (need to continue taking the medicine). After stopping treatment with Preato, withdrawal symptoms may occur (see section 3 "How to take Preato" and "Stopping Preato"). If the patient is concerned that they may become dependent on Preato, they should discuss this with their doctor.
If the patient experiences any of the following symptoms while taking Preato, 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 but being unable to do so
• Feeling unwell after stopping the medicine and feeling better after taking it again If the patient experiences any of these symptoms, they should discuss them with their doctor to determine the best course of treatment, including when to stop taking the medicine and how to do so safely.

Children and adolescents

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

Preato and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Preato and some other medicines may interact with each other (interactions).
Taking Preato with other medicines that have a sedating effect (e.g., opioids) may increase these effects and cause respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if Preato is taken with medicines containing:

• Oxycodone - (painkiller)
• Lorazepam - (medicine used for anxiety)
• Alcohol

Preato can be taken with oral contraceptives.

Preato with food, drink, and alcohol

Preato tablets can be taken with or without food.
It is recommended that the patient does not drink alcohol while taking Preato.

Pregnancy and breastfeeding

Preato should not be taken during pregnancy or breastfeeding, unless the doctor decides otherwise. Taking pregabalin during the first 3 months of pregnancy may cause birth defects in the unborn child that require treatment. A Scandinavian study analyzing data from women who took pregabalin during the first 3 months of pregnancy found birth defects in 6 out of every 100 babies born, whereas in women who were not treated with pregabalin, birth defects occurred in 4 out of every 100 babies born. The reported birth defects involved the face (cleft lip and palate), eyes, nervous system (including the brain), kidneys, and genital organs.
Women of childbearing age should use effective contraception. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Preato may cause dizziness, somnolence, and decreased concentration. The patient should not drive a car, operate complex machines, or perform potentially hazardous activities until they have determined the effect of the medicine on their ability to perform these activities.

3. How to take Preato

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist. The patient should not take more of the medicine than prescribed.
The doctor will determine the dose of the medicine that is most suitable for the patient.
Preato is for oral use only.

Neuropathic pain of peripheral and central origin, epilepsy, or generalized anxiety disorder:

• The patient should take the number of tablets as prescribed by the doctor.
• The recommended dose for the patient will be between 150 mg and 600 mg per day.
• The doctor will inform the patient whether to take Preato twice or three times a day. If taken twice a day, Preato should be taken in the morning and evening at the same time every day. If taken three times a day, Preato should be taken in the morning, at noon, and in the evening at the same time every day.

If the patient feels that Preato is too strong or too weak, they should inform their doctor or pharmacist.
Patient over 65 years old should take Preato according to the scheme presented, unless they have kidney disease.
In patients with impaired kidney function, the doctor may decide on a different dosing schedule and/or change the dose of the medicine.
The tablet should be swallowed whole and washed down with water.
Preato should be taken for as long as the doctor prescribes, and the treatment can only be stopped on the doctor's advice.

Taking a higher dose of Preato than prescribed

The patient should inform their doctor or go to the nearest hospital emergency department immediately. The patient should take the Preato packaging with them. After taking a higher dose of Preato than prescribed, the patient may feel sleepy, confused, agitated, or restless. There have also been reports of seizures and loss of consciousness (coma).

Missing a dose of Preato

It is important to take Preato tablets regularly at the same times every day. If a dose is missed, the patient should take it as soon as possible, unless it is almost time for the next dose. In this case, the patient should continue treatment according to the prescribed schedule. The patient should not take a double dose to make up for the missed dose.

Stopping Preato

The patient should not stop taking Preato suddenly. If the patient wants to stop taking Preato, they should first talk to their doctor. The doctor will inform them how to do this. If treatment needs to be stopped, it should be done gradually over at least one week. The patient should be aware that after stopping short-term or long-term treatment with Preato, certain 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 the patient has taken Preato for a longer period. If withdrawal symptoms occur, the patient should contact their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

Very common - may affect more than 1 in 10 people:

Dizziness, somnolence, headache

Common - may affect up to 1 in 10 people:

• Increased appetite
• Mood swings, confusion, disorientation, decreased sexual desire, irritability
• Difficulty concentrating, clumsiness, memory disturbances, memory loss, tremors, speech disturbances, tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal

Blurred vision, double vision

• Dizziness, balance disturbances, falls
• Dry mouth, constipation, vomiting, bloating, diarrhea, nausea, feeling of abdominal distension
• Difficulty achieving an erection
• Body swelling, including limb swelling
• Feeling drunk, ataxia
• Weight gain
• Muscle spasms, 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, restlessness, depression, agitation, mood swings, difficulty finding the right words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychotic 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, jerky movements, 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, tearing, 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 flashes
• Breathing difficulties, feeling of dryness in the nose, feeling of a blocked nose
• Increased saliva production, heartburn, feeling of numbness 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 urination, urinary incontinence
• Weakness, thirst, chest tightness
• Changes in blood test results and liver function (increased creatine phosphokinase activity, alanine aminotransferase, and aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine levels in the blood, decreased potassium levels in the blood)
• Hypersensitivity, facial swelling, itching, hives, 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 rocking, altered sense of depth, bright vision, loss of vision
• Dilated pupils, strabismus
• Cold sweats, tightness in the throat, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slowed or restricted movements
• Difficulty writing
• Ascites
• Fluid in the lungs
• Seizures
• Changes in ECG tracing corresponding to heart rhythm disturbances
• Muscle damage
• Breast discharge, breast hypertrophy, gynecomastia
• Amenorrhea
• Kidney failure, decreased urine output, urinary retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal behavior, suicidal thoughts
• Allergic reactions (which may be characterized by difficulty breathing, eye inflammation, and severe skin reactions with red, flat, plate-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 severe 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)
• Parkinsonian syndrome, 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 Preato ("drug dependence")

The patient should be aware that after stopping short-term or long-term treatment with pregabalin, certain side effects may occur, known as withdrawal symptoms (see section "Stopping Preato").

If the patient experiences swelling of the face or tongue, or if a skin rash with blisters or peeling occurs, they should seek medical attention immediately.

Some side effects, such as somnolence, 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 severity of these effects may be greater when such medicines are taken concomitantly.
After the marketing authorization of the medicine, the following side effects have been reported: breathing difficulties, shallow breathing.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products, ul. 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, more information can be gathered on the safety of the medicine.

5. How to store Preato

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
The batch number is stated on the label and carton after the abbreviation (Lot).
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Preato contains

The active substance of Preato 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 the inscription "I" on one side, 5 mm in diameter
50 mg tablets
Round, biconvex tablets with the inscription "M1" on one side, 7 mm in diameter
75 mg tablets
Round, biconvex tablets with the inscription "I1" on one side, 8 mm in diameter
100 mg tablets
Round, biconvex tablets with the inscription "M2" on one side, 9 mm in diameter
150 mg tablets
Round, biconvex tablets with the inscription "I2" on one side, 10 mm in diameter
200 mg tablets
Round, biconvex tablets with the inscription "M3" on one side, 12 mm in diameter
225 mg tablets
Round, biconvex tablets with the inscription "M7" on one side, 12 mm in diameter
300 mg tablets
Oval, biconvex tablets with the inscription "I3" on one side, 20 mm in length and 8 mm in width
The pack contains blisters of PA/Aluminum/PVC/Aluminum foil containing 14, 28, 56, 84 tablets.

Marketing authorization 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

Date of last revision of the leaflet: 01/2024