Pregabalin pharmalab

Package leaflet: Information for the user

Pregabalin Pharmalab, 75 mg, hard capsules
Pregabalin Pharmalab, 150 mg, hard capsules
Pregabalin Pharmalab, 300 mg, hard capsules
Pregabalinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them 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.

Contents of the leaflet

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

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

Pregabalin Pharmalab 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
  Pregabalin Pharmalab 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, stabbing, tingling, or numbness, or as sharp pain, cramps, aching, or pins and needles. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, and fatigue, which may affect the patient's physical and social functioning and overall quality of life.

• Epilepsy
  Pregabalin Pharmalab is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor may prescribe Pregabalin Pharmalab if your current treatment does not fully control your condition. Pregabalin Pharmalab should always be used as an add-on to your current antiepileptic therapy. Pregabalin Pharmalab must not be used as monotherapy, but always in combination with other antiepileptic medicines.

• Generalized anxiety disorder
  Pregabalin Pharmalab 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 motoric restlessness, nervousness or feeling keyed up, easy fatigability, difficulty concentrating or a sensation of "mind going blank", irritability, increased muscle tension, or sleep disturbances.
  These symptoms are different from the stress and tension associated with everyday life.

2. Important information before using Pregabalin Pharmalab

When not to use Pregabalin Pharmalab
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 Pregabalin Pharmalab, discuss this with your doctor or
pharmacist.

• Some patients taking pregabalin have experienced symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, and 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 experiences any symptoms of severe skin reactions listed in section 4, pregabalin should be discontinued immediately and medical help sought without delay.
• Pregabalin has been associated with dizziness and somnolence, which may lead to an increased risk of accidental injury (falls), especially in elderly patients. Therefore, caution should be exercised until the patient becomes familiar with the possible effects of the medicine.
• Treatment with Pregabalin Pharmalab may cause blurred vision, loss of vision, or other visual disturbances, most of which are temporary. If any changes in vision occur, inform your doctor immediately.
• In diabetic patients, weight gain during treatment with pregabalin may necessitate adjustment of antidiabetic therapy.
• Certain adverse effects, such as somnolence, may occur more frequently when patients are taking other medicines, e.g. analgesics or muscle relaxants, which have similar adverse effects to pregabalin. The severity of these effects may be greater when such medicines are taken concomitantly.
• Cases of heart failure have been reported in some patients treated with Pregabalin Pharmalab, particularly in elderly patients with cardiovascular disorders. Before using this medicine, inform your doctor if you have a history of heart disease.
• Cases of renal failure have been reported in some patients taking pregabalin. If during treatment with Pregabalin Pharmalab the patient notices a decrease in frequency of urination, inform your doctor. This symptom may resolve after discontinuation of the medicine.
• A small number of patients taking antiepileptic medicines, such as Pregabalin Pharmalab, 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 Pregabalin Pharmalab is used concomitantly with other medicines that may cause constipation (such as certain analgesics), gastrointestinal problems (e.g. constipation, bowel obstruction, or intestinal paralysis) may occur. Inform your doctor if the patient experiences constipation, especially if there is a predisposition to it.
• Before starting treatment with 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 Pharmalab.
• Seizures have been reported during treatment with pregabalin or shortly after discontinuation. 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 treated with pregabalin. Inform your doctor about all serious medical conditions the patient has had, including liver or kidney disease.
• Cases of breathing difficulties have been reported. If the patient has neurological disorders, respiratory disorders, 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 Pregabalin Pharmalab (the need to continue taking the medicine). Withdrawal symptoms may occur after stopping Pregabalin Pharmalab (see section 3, "How to take Pregabalin Pharmalab" and "Stopping Pregabalin Pharmalab"). If the patient is concerned about possibly becoming dependent on Pregabalin Pharmalab, they should discuss this with their doctor.
If the patient notices any of the following symptoms while taking Pregabalin Pharmalab, this 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 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 discuss them with their doctor to review the best course of treatment, including when and how to discontinue this 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.
Pregabalin Pharmalab and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Pregabalin Pharmalab and certain medicines may interact with each other. Pregabalin Pharmalab taken concomitantly with other central nervous system depressants (including opioids) may enhance these effects and lead to respiratory depression, coma, and death.
The degree of dizziness, drowsiness, and reduced concentration may increase if Pregabalin Pharmalab is taken together with medicines containing:

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

Pregabalin Pharmalab may be used concomitantly with oral contraceptives.
Taking Pregabalin Pharmalab with food, drink, and alcohol
Pregabalin Pharmalab capsules may be taken with or without food.
Alcohol should not be consumed during treatment with Pregabalin Pharmalab.
Pregnancy and breastfeeding
Pregabalin Pharmalab should not be used during pregnancy or breastfeeding unless otherwise decided by the doctor. Use of pregabalin in women during the first three months of pregnancy may cause congenital malformations in the unborn child requiring treatment. In a Scandinavian country study analyzing data from women who took pregabalin during the first trimester of pregnancy, congenital malformations were observed 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/palate), eyes, nervous system (including the brain), kidneys, and genital organs.
Driving and operating machinery
Pregabalin Pharmalab may cause dizziness, drowsiness, and reduced concentration. Do not drive, operate complex machinery, or perform potentially hazardous activities until the effect of this medicine on the ability to perform such tasks has been determined.

3. How to take Pregabalin Pharmalab

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

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

If the patient feels that Pregabalin Pharmalab is too strong or not effective enough, they should inform their doctor or pharmacist.
Patients over 65 years of age should take Pregabalin Pharmalab 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.
The capsule should be swallowed whole with water.
Pregabalin Pharmalab should be taken for as long as directed by the doctor.
Taking more Pregabalin Pharmalab than prescribed
Inform your doctor or go immediately to the nearest hospital emergency department. Bring the medicine packaging or bottle with you. After taking an overdose of Pregabalin Pharmalab, the patient may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.
If you miss a dose of Pregabalin Pharmalab
It is important to take Pregabalin Pharmalab 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 treatment according to the prescribed schedule. Do not take a double dose to make up for a missed dose.
Stopping Pregabalin Pharmalab
Do not stop taking Pregabalin Pharmalab suddenly. If the patient wishes to discontinue treatment with Pregabalin Pharmalab, 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. Be aware that after short- or long-term treatment with Pregabalin Pharmalab, certain adverse effects, known as withdrawal symptoms, may occur. These symptoms 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 Pregabalin Pharmalab 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 reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.

Very common: may affect more than 1 in 10 people

• Dizziness, drowsiness, headache.

Common: may affect 1 in 10 people

• Increased appetite.
• Euphoria, confusion, disorientation, decreased libido, irritability.
• Difficulty concentrating, clumsiness, memory impairment, amnesia, tremor, speech difficulties, tingling sensation, numbness, sedation, lethargy, insomnia, feeling of fatigue, unusual feeling.
• Blurred vision, double vision.
• Dizziness, loss of balance, fall.
• Dry mouth, constipation, vomiting, bloating, diarrhoea, nausea, feeling of abdominal distension.
• Erectile dysfunction.
• Swelling of the body, including limbs.
• Feeling of alcohol intoxication, unsteady gait.
• Weight gain.
• Muscle cramps, joint pain, back pain, limb pain.
• Sore throat.

Uncommon: may affect 1 in 100 people

• Loss of appetite, weight loss, low blood sugar, high blood sugar.
• Disturbances in self-perception, psychomotor agitation, depression, restlessness, mood changes, difficulty finding words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychiatric disorders, difficulty thinking, increased libido, sexual problems including inability to achieve orgasm, delayed ejaculation.
• Visual disturbances, abnormal eye movements, visual impairment including tunnel vision, perception of flashes of light, jerky movements, reduced reflexes, increased activity, dizziness upon standing, skin hypersensitivity, loss of taste, burning sensation, intention tremor, disturbances in consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise.
• Dry eyes, eye swelling, eye pain, impaired eye movement, 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 face, sudden hot flushes.
• Breathing difficulties, dry nose sensation, nasal congestion.
• Increased salivation, heartburn, tingling sensation around the mouth.
• Sweating, rash, chills, fever.
• Muscle twitching, 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 and liver function results (increased creatine kinase, alanine aminotransferase and aspartate aminotransferase activity, decreased platelet count, neutropenia, increased blood creatinine concentration, decreased blood potassium concentration).
• Hypersensitivity, facial swelling, itching, urticaria, rhinitis, nosebleeds, cough, snoring.
• Painful menstruation.
• Cold hands and feet.

Rare: may affect 1 in 1,000 people

• Altered sense of smell, sensation of oscillating vision, altered depth perception, vivid vision, vision loss.
• Dilated pupils, strabismus.
• Cold sweats, throat tightness, tongue swelling.
• Pancreatitis.
• Difficulty swallowing.
• Slowed or limited movements.
• Writing difficulties.
• Ascites.
• Pulmonary oedema.
• Seizures.
• ECG changes indicating heart rhythm disturbances.
• Muscle damage.
• Nipple discharge, breast enlargement, gynaecomastia in males.
• Absence of menstruation.
• Kidney failure, reduced urine volume, urinary retention.
• Decreased white blood cell count.
• Inappropriate behaviour, suicidal behaviour, suicidal thoughts.
• Allergic reactions, which may include breathing difficulties, eye inflammation (keratitis), and serious skin reactions characterised by red, flat, disc-shaped or round spots on the trunk, often with blisters in the centre, skin peeling, oral, throat, nose, genital or ocular 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 movement ability), and rigidity (muscle stiffness).

Very rare: may affect 1 in 10,000 people

• Liver failure.
• Viral hepatitis (liver inflammation).

Frequency not known: frequency cannot be estimated from available data

• Dependence on Pregabalin Pharmalab (‘drug dependence’).

It should be noted that after discontinuation of short- or long-term treatment with Pregabalin Pharmalab, certain adverse reactions, known as withdrawal symptoms, may occur (see section “Discontinuation of Pregabalin Pharmalab”).

If facial or tongue swelling occurs, or if skin redness appears with accompanying blisters or skin peeling, seek immediate medical advice.

Some adverse reactions, such as drowsiness, may occur more frequently when patients are taking other medicines, e.g. analgesics or muscle relaxants, which have similar adverse 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 adverse reactions have also been reported: breathing difficulties, shallow breathing.

Reporting of adverse reactions

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Pregabalin Pharmalab

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box, bottle,
and blister after: EXP. The expiry date refers to the last day of the specified month.
No special storage instructions are required for this medicine.
Medicines must not be disposed of via the sewage system or in household waste. Ask
your pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Pregabalin Pharmalab contains
The active substance is pregabalin. Each hard capsule contains 75 mg, 150 mg, or 300 mg of
pregabalin.
Other ingredients: mannitol (E 421), talc;
Capsule shell composition: titanium dioxide (E 171), iron oxide red (E 172) (only for 75 mg and
300 mg), gelatin, purified water;
Printing ink composition: shellac (E 904), iron oxide black (E 172), propylene glycol (E 1520),
potassium hydroxide (E 525).
What Pregabalin Pharmalab looks like and contents of the pack
Capsules, 75 mg: orange cap and white body of the capsule, size 4, printed with black ink
“PGBN 75” on the body, filled with white or almost white powder.
Capsules, 150 mg: white cap and white body of the capsule, size 2, printed with black ink “PGBN 150”
on the capsule body, filled with white or almost white powder.
Capsules, 300 mg: orange cap and white body of the capsule, size 0, printed with black ink
“PGBN 300” on the capsule body, filled with white or almost white powder.
Pregabalin Pharmalab is packed in blisters made of PVC/Aclar/Aluminum or blisters made of
Aluminum/PVC/PVdC, placed in a cardboard box.
Pack sizes: 14, 21, 56, 70, 84, 100, and 112 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Pharmalab Poland Sp. z o.o.
ul. Siemianowicka 84
41-902 Bytom
[email protected]
Importer:
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA3000
Malta
This medicinal product is authorised in the European Economic Area countries under the
following names:
Portugal Pregabalina Vivanta
Czech Republic Tirdabix
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 kemény kapszula
Poland Pregabalin Pharmalab
Netherlands Pregabaline Vivanta 25 mg/50 mg/75 mg/100 mg/150 mg/200 mg/225
mg/300 mg harde capsules
Romania Pregabalina Vivanta 75 mg capsule
Pregabalina Vivanta 150 mg capsule
Pregabalina Vivanta 300 mg capsule