Pregabalin Vivanta

Leaflet attached to 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

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 further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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, you should tell your 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 pack 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 damage to the nerves. 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, cramp, 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. Your doctor may prescribe Pregabalin Vivanta if your current treatment does not fully control your condition. Pregabalin Vivanta should always be used as an add-on therapy to your current treatment. Pregabalin Vivanta should not be used as monotherapy, but always in combination with other anti-epileptic medicines.
• 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 irritable, difficulty concentrating, or feeling "empty in the head", irritability, increased muscle tension, or sleep disturbances. The symptoms are different from the stress and tension of everyday life.

symptoms are different from the stress and tension of everyday life.

2. Important information before taking Pregabalin Vivanta

When not to take Pregabalin Vivanta

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

Warnings and precautions

You should discuss this with your doctor or pharmacist before taking Pregabalin Vivanta.

• Some patients taking pregabalin have experienced symptoms suggesting an allergic reaction. These symptoms included swelling of the face, lips, tongue, and throat, as well as a rash. If you experience any of these symptoms, you should contact your doctor immediately.
• Pregabalin has been associated with severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. If you experience any of the symptoms of serious skin reactions listed in section 4, you should stop taking pregabalin and seek medical attention immediately.
• Pregabalin has been associated with dizziness and somnolence, which may increase the risk of accidental injury (falls) in elderly people. Therefore, you should exercise caution until you are familiar with the effects of the medicine.
• Taking Pregabalin Vivanta may cause blurred vision, double vision, or other vision disturbances, most of which are temporary. If you experience any changes in your vision, you should inform your doctor immediately.
• Patients with diabetes who gain weight while taking pregabalin may need to have their anti-diabetic treatment adjusted.
• Certain side effects, such as drowsiness, may occur more frequently when patients take other medicines that have similar side effects to pregabalin. 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 Pregabalin Vivanta; mainly in elderly patients with cardiovascular conditions. You should inform your doctor if you have a history of heart disease.
• There have been reports of kidney failure in some patients taking pregabalin. If you experience a decrease in urine output while taking Pregabalin Vivanta, you should inform your doctor. This symptom may resolve after discontinuation of the medicine.
• A small number of patients taking anti-epileptic medicines, such as Pregabalin Vivanta, have had thoughts of harming themselves or suicide, or have exhibited suicidal behavior. If you have ever had such thoughts or behavior, you should contact your doctor immediately.
• If Pregabalin Vivanta is taken with other medicines that can cause constipation (such as certain painkillers), gastrointestinal problems (such as constipation, obstruction, or paralytic ileus) may occur. You should inform your doctor if you experience constipation, especially if you are prone to it.
• Before taking this medicine, you should inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, 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 you experience seizures, you should contact your doctor immediately.
• There have been reports of brain dysfunction (encephalopathy) in some patients with other conditions who took pregabalin. You should inform your doctor about any serious medical conditions you have had, including liver or kidney disease.
• There have been reports of breathing difficulties. If you have neurological disorders, respiratory disorders, kidney disorders, or are over 65 years old, your doctor may recommend a different dosing schedule. If you experience breathing difficulties or shallow breathing, you should contact your 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 you are concerned that you may become dependent on Pregabalin Vivanta, you should discuss this with your doctor.
If you experience 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 you experience any of these symptoms, you should discuss them with your 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 Pregabalin Vivanta in children and adolescents (under 18 years of age) have not been established, and therefore pregabalin should not be used in this age group.

Pregabalin Vivanta and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
Pregabalin Vivanta and some medicines may interact with each other (interactions). Pregabalin Vivanta taken with other medicines that have a sedating effect (e.g. opioids) may increase these effects and cause respiratory failure, coma, and death.
The severity of dizziness, drowsiness, 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.
You should not drink alcohol while taking Pregabalin Vivanta.

Pregnancy and breastfeeding

Pregabalin Vivanta should not be taken during pregnancy or breastfeeding, unless your doctor decides otherwise. Taking pregabalin during the first 3 months of pregnancy may cause birth defects in the unborn baby that require treatment. A study in Scandinavian countries analyzed data from women who took pregabalin during the first 3 months of pregnancy and found birth defects in 6 out of every 100 babies born, while in women who did not take pregabalin, birth defects occurred in 4 out of every 100 babies born. The reported birth defects included facial defects (cleft lip and palate), eye defects, nervous system defects (including brain defects), kidney defects, and genital defects.

Driving and using machines

Pregabalin Vivanta may cause dizziness, drowsiness, and decreased concentration. You should not drive, operate complex machinery, or perform potentially hazardous activities until you have determined how this medicine affects your ability to perform these activities.

3. How to take Pregabalin Vivanta

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should ask your doctor or pharmacist. Do not take more than the prescribed dose of the medicine.
Your doctor will determine the dose that is right for you. Pregabalin Vivanta is for oral use only.

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

• You should take the number of capsules prescribed by your doctor.
• The recommended dose for you will be between 150 mg and 600 mg per day.
• Your doctor will tell you whether to take Pregabalin Vivanta twice or three times a day. If you take it twice a day, you should take it in the morning and evening at the same time every day. If you take it three times a day, you should take it in the morning, at noon, and in the evening at the same time every day.

If you feel that the effect of Pregabalin Vivanta is too strong or too weak, you should tell your doctor or pharmacist.
Patients over 65 years of age should take Pregabalin Vivanta according to the recommended schedule, 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 of the medicine.
The capsule should be swallowed whole and washed down with water.
You should take Pregabalin Vivanta for as long as your doctor prescribes it.

Taking a higher dose of Pregabalin Vivanta than prescribed

You should inform your doctor or go to the nearest hospital emergency department immediately. You should take the packaging or bottle of Pregabalin Vivanta with you. After taking a higher dose of Pregabalin Vivanta than prescribed, you 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 you miss a dose, you should take it as soon as possible, unless it is almost time for your next dose. In this case, you should continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Pregabalin Vivanta

You should not stop taking Pregabalin Vivanta suddenly. If you want to stop taking Pregabalin Vivanta, you should first talk to your doctor. Your doctor will tell you how to do this. If treatment needs to be stopped, it should be done gradually over at least one week. You should be aware that after stopping short-term or long-term treatment with Pregabalin Vivanta, 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 you have taken Pregabalin Vivanta for a longer period. If you experience withdrawal symptoms, you should contact your doctor. If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

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, drowsiness, headache.

Common:may affect up to 1 in 10 people

• Increased appetite.
• Mood swings, confusion, disorientation, decreased sexual interest, 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.
• Swelling of the body, including limbs.
• Feeling drunk, unsteady gait.
• 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.

sexual problems, including inability to achieve orgasm, delayed ejaculation.

• Changes in vision, unusual 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, tremors when moving, disturbances of 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, back pain.
• Chest pain.
• Difficulty urinating or painful urination, urinary incontinence.
• Weakness, thirst, tightness in the chest.
• 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, runny nose, 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, 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 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 characterized by 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).

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.
• Viral hepatitis (hepatitis).

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

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

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

If you experience facial swelling or tongue swelling, or if you develop a rash with blisters or peeling, you should seek medical attention immediately.

Certain side effects, such as drowsiness, may occur more frequently when patients take other medicines that have similar side effects to pregabalin. The severity of these effects may be greater when such medicines are taken concomitantly.
After the medicine was placed on the market, the following side effects were also reported: breathing difficulties, shallow breathing.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pregabalin Vivanta

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, and blister after EXP. The expiry date refers to the last day of the month stated.
There are no special storage instructions for the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 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;
Cap shell composition:titanium dioxide (E 171), iron oxide red (E 172) (only for 75 mg and 300 mg), gelatin, purified water;
Ink composition: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 capsules

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 capsules
Pregabalina Vivanta 150 mg capsules
Pregabalina Vivanta 300 mg capsules

Date of last revision of the leaflet: