Pregabalin Vivanta

Leaflet accompanying the packaging: information for the user

Pregabalin Vivanta, 75 mg, hard capsules

Pregabalin Vivanta, 150 mg, hard capsules

Pregabalin Vivanta, 300 mg, hard capsules

Pregabalin

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.

• This leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 Pregabalin Vivanta and what is it used for
• 2. Important information before taking Pregabalin Vivanta
• 3. How to take Pregabalin Vivanta
• 4. Possible side effects
• 5. How to store Pregabalin Vivanta
• 6. Contents of the packaging and other information

1. What is Pregabalin Vivanta and what is it used for

Pregabalin Vivanta belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalized anxiety disorder in adults.

• Neuropathic pain of peripheral and central originPregabalin Vivanta 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, 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.
• EpilepsyPregabalin Vivanta is used to treat certain types of epilepsy (partial seizures, with or without secondary generalization) in adults. The doctor may prescribe Pregabalin Vivanta if the current treatment does not fully control the disease. Pregabalin Vivanta should always be used as an add-on therapy to the currently used treatment. Pregabalin Vivanta should not be used as monotherapy, but always in combination with other antiepileptic drugs.
• Generalized anxiety disorderPregabalin Vivanta is used to treat generalized anxiety disorder (GAD). The symptoms of GAD include prolonged, excessive anxiety and worry that is difficult to control. GAD can also cause restlessness, feeling on edge or irritability, fatigue, difficulty concentrating or feeling of "empty head", irritability, increased muscle tension or sleep disturbances. The symptoms are different from the stress and tension of everyday life.

and sleep disturbances.

2. Important information before taking Pregabalin Vivanta

When not to take Pregabalin Vivanta

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 Pregabalin Vivanta, the doctor or pharmacist should be consulted.

• In some patients taking pregabalin, symptoms suggesting an allergic reaction have occurred. These symptoms included swelling of the face, lips, tongue, and throat, as well as a widespread skin rash. If any of these symptoms occur, the doctor should be contacted immediately.
• Pregabalin has been associated with reports of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. If the patient experiences any of the symptoms of serious skin reactions mentioned in section 4, they should stop taking pregabalin and seek medical attention immediately.
• Pregabalin has been associated with dizziness and somnolence, which may increase the risk of accidental injuries (falls) in elderly people. Therefore, caution should be exercised until the effects of the medicine are known.
• Taking Pregabalin Vivanta may cause blurred vision, loss of vision, or other vision disturbances, most of which are temporary. If any changes in vision occur, the doctor should be informed immediately.
• In patients with diabetes who gain weight during pregabalin treatment, it may be necessary to adjust the antidiabetic treatment.
• Some side effects, such as somnolence, may occur more frequently when patients take other medicines, e.g., painkillers or muscle relaxants, with similar side effects to pregabalin. The intensity of these effects may be greater when such medicines are taken concomitantly.
• There have been reports of heart failure in some patients taking Pregabalin Vivanta; mainly in the elderly with cardiovascular disorders. Before taking this medicine, the doctor should be informed about any history of heart disease.
• There have been reports of kidney failure in some patients taking pregabalin. If the patient notices a decrease in urine output while taking Pregabalin Vivanta, they should inform their doctor. This symptom may resolve after discontinuation of the medicine.
• A small number of patients taking antiepileptic drugs, such as Pregabalin Vivanta, 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.
• If Pregabalin Vivanta 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 doctor should be informed if the patient experiences constipation, especially if they are prone to it.
• Before starting to take this medicine, the doctor should be informed if the patient has ever abused or been dependent on alcohol, prescription drugs, or any illegal psychoactive substances; this may indicate an increased risk of dependence on Pregabalin Vivanta.
• There have been reports of seizures during pregabalin treatment or shortly after discontinuation. If seizures occur, the doctor should be contacted immediately.
• There have been reports of brain function impairment (encephalopathy) in some patients with other diseases who took pregabalin. The doctor should be informed about all serious diseases, 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 Pregabalin Vivanta (need to continue taking the medicine). After stopping Pregabalin Vivanta, withdrawal symptoms may occur (see section 3, "How to take Pregabalin Vivanta" and "Stopping Pregabalin Vivanta").
If the patient is concerned that they may become dependent on Pregabalin Vivanta, they should discuss this with their doctor.
If the patient experiences any of the following symptoms while taking Pregabalin Vivanta, 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 without success
• 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 it safely.

Children and adolescents

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

Pregabalin Vivanta and other medicines

The doctor or pharmacist should be told about all medicines the patient is taking, has recently taken, or plans to take.
Pregabalin Vivanta and some medicines may interact with each other (interactions). Pregabalin Vivanta taken with other medicines with 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 Pregabalin Vivanta is taken with medicines containing:

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

Pregabalin Vivanta can be taken with oral contraceptives.

Taking Pregabalin Vivanta with food, drink, and alcohol

Pregabalin Vivanta capsules can be taken with or without food.
Alcohol should not be consumed while taking Pregabalin Vivanta.

Pregnancy and breastfeeding

Pregabalin Vivanta 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 baby that require treatment. In a Scandinavian study, analysis of data from women who took pregabalin during the first 3 months of pregnancy showed birth defects in 6 out of every 100 babies born, while in women who were not treated with pregabalin, birth defects occurred in 4 out of every 100 babies born. The reported birth defects included face (cleft lip and palate), eye, nervous system (including brain), kidney, and genital defects.

Driving and using machines

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

3. How to take Pregabalin Vivanta

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the doctor or pharmacist should be consulted. The medicine should not be taken in larger doses than prescribed.
The doctor will determine the dose of the medicine that is most suitable for the patient. Pregabalin Vivanta is intended for oral use only.

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

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

If the patient feels that Pregabalin Vivanta is too strong or too weak, they should inform their doctor or pharmacist.
Patients over 65 years of age should take Pregabalin Vivanta according to the presented schedule, 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 capsule should be swallowed whole and washed down with water.
Pregabalin Vivanta should be taken for as long as prescribed by the doctor.

Taking a higher dose of Pregabalin Vivanta than prescribed

The doctor or the nearest hospital emergency department should be informed immediately. The packaging or bottle of Pregabalin Vivanta should be taken along. After taking a higher dose of Pregabalin Vivanta than prescribed, the patient may feel drowsy, confused, agitated, or restless. There have also been reports of seizures and loss of consciousness (coma).

Missing a dose of Pregabalin Vivanta

It is important to take Pregabalin Vivanta regularly at the same times every day. If a dose is missed, it should be taken as soon as possible, unless it is almost time for the next dose. In this case, the treatment should be continued according to the prescribed schedule. A double dose should not be taken to make up for the missed dose.

Stopping Pregabalin Vivanta

Pregabalin Vivanta should not be stopped suddenly. If the patient wants to stop taking Pregabalin Vivanta, they should first discuss it with their doctor. The doctor will inform them how to do it. If the treatment needs to be stopped, it should be done gradually over at least one week. It should be known that after stopping short-term or long-term treatment with Pregabalin Vivanta, certain side effects, known as withdrawal symptoms, may occur. 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 Pregabalin Vivanta for a longer period. If withdrawal symptoms occur, the doctor should be contacted. If there are any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Pregabalin Vivanta 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 interest, irritability.
• Difficulty concentrating, clumsiness, memory impairment, memory loss, tremors, speech disturbances, tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling of strangeness.
• 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 of intoxication, 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, mental disorders, difficulty thinking, increased sexual interest, sexual problems, including inability to achieve orgasm, delayed ejaculation.

and sexual problems.

• Changes in vision, abnormal eye movements, vision disturbances, including tunnel vision, flashes of light, nystagmus, decreased reflexes, increased activity, dizziness when standing up, skin hypersensitivity, loss of taste, feeling of burning, tremors 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, accelerated heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure.
• Sudden flushing of the face, sudden hot flashes.
• Breathing difficulties, feeling of dryness in the nose, feeling of a blocked nose.
• Increased salivation, heartburn, feeling of numbness around the mouth.
• Sweating, rash, chills, fever.
• Muscle twitching, joint swelling, muscle stiffness, pain, including muscle pain, back 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, coughing, snoring.
• Painful menstruation.
• Cold hands and feet.

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

• Changed sense of smell, feeling of swaying, changed sense of depth, bright vision, loss of vision.
• Dilated pupils, strabismus.
• Cold sweats, throat tightness, tongue swelling.
• Pancreatitis.
• Difficulty swallowing.
• Slowed or limited movements.
• Difficulty writing.
• Ascites.
• Fluid in the lungs.
• Seizures.
• Changes in the ECG recording corresponding to heart rhythm disturbances.
• Muscle damage.
• Breast discharge, breast enlargement, 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 (keratitis), and severe skin reactions with red, flat, plate-like, or round patches on the torso, often with blisters in their 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).

and toxic epidermal necrolysis.

• Jaundice (yellowing of the skin and whites of the eyes).
• Parkinson's 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.
• Viral hepatitis (hepatitis).

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

• Dependence on Pregabalin Vivanta ("drug dependence").

It should be noted that after stopping short-term or long-term treatment with Pregabalin Vivanta, certain side effects, known as withdrawal symptoms, may occur (see section "Stopping Pregabalin Vivanta").

If facial swelling or tongue swelling occurs, or if skin redness with accompanying blisters or peeling occurs, medical attention should be sought immediately.

Some side effects, such as somnolence, may occur more frequently when patients take other medicines, e.g., painkillers or muscle relaxants, with similar side effects to pregabalin. The intensity of these effects may be greater when such medicines are taken concomitantly.
After the marketing authorization of the medicine, the following side effects have also been reported: breathing difficulties, shallow breathing.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Pregabalin Vivanta

The medicine should be stored out of sight and reach of children.
Pregabalin Vivanta should not be taken after the expiry date stated on the carton, bottle, and blister after: EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pregabalin Vivanta contains

The active substance of the medicine is pregabalin. Each hard capsule contains 75 mg, 150 mg, or 300 mg of pregabalin.
Other ingredients are:mannitol (E 421), talc;
Capsule shell:titanium dioxide (E 171), iron oxide red (E 172) (only for 75 mg and 300 mg), gelatin, purified water;
Printing ink:shellac (E 904), iron oxide black (E 172), propylene glycol (E 1520), potassium hydroxide (E 525).

What Pregabalin Vivanta looks like and contents of the pack

Capsules, 75 mg:orange cap and white body, size 4, with black printing "PGBN 75" on the body, filled with white or off-white powder.
Capsules, 150 mg:white cap and white body, size 2, with black printing "PGBN 150" on the body, filled with white or off-white powder.
Capsules, 300 mg:orange cap and white body, size 0, with black printing "PGBN 300" on the body, filled with white or off-white powder.
Pregabalin Vivanta is packaged in PVC/Aclar/Aluminum or Aluminum/PVC/PVdC blisters in a cardboard box.
Package sizes:14, 21, 56, 70, 84, 100, and 112 hard capsules.
Not all package sizes may be marketed.

Marketing authorization holder:

Pharmalab Poland Sp. z o.o.
ul. Siemianowicka 84
41-902 Bytom
info@pharmalab.pl

Importer:

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA3000
Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal
Pregabalina Vivanta
Czech Republic
Pregabalin Vivanta
Germany
Pregabalin Vivanta 25 mg/50 mg/75 mg/100 mg/150 mg/200 mg/225 mg/300 mg Hartkapseln
Hungary
Pregabalin Vivanta 75 mg/150 mg/300 mg hard capsule
Poland
Pregabalin Vivanta
Netherlands
Pregabaline Vivanta 25 mg/50 mg/75 mg/100 mg/150 mg/200 mg/225 mg/300 mg hard capsules
Romania
Pregabalina Vivanta 75 mg capsule
Pregabalina Vivanta 150 mg capsule
Pregabalina Vivanta 300 mg capsule

Date of last revision of the leaflet: