PREGABALIN 25 mg Hard Capsules

Зміст інструкції

1. Pregabalin Aristo 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   1. What is Pregabalin Aristo and what it is used for
   2. What you need to know before taking Pregabalin Aristo
   3. How to take Pregabalin Aristo
   4. Possible side effects
   5. How to store Pregabalin Aristo
   6. Package contents and other information

Pregabalin Aristo 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Pregabalin Aristo 225 mg hard capsules
Pregabalin Aristo 300 mg hard capsules
Pregabalin
Generic medicine
Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Pregabalin Aristo belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.

Peripheral and central neuropathic pain:Pregabalin Aristo is used to treat long-lasting pain caused by damage to the nervous system. Various diseases can cause neuropathic pain, such as diabetes or herpes zoster.
Pain sensations can be described as heat, burning, throbbing, shooting pains, stabbing pains, acute pains, cramp-like pains, suffering, tingling, numbness and piercing pains. Peripheral and central neuropathic pain can also be associated with mood changes, sleep disturbances and fatigue (tiredness) and can have an impact on physical and social activity and overall quality of life.

Epilepsy:Pregabalin Aristo is used to treat certain forms of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Pregabalin Aristo to help you treat your epilepsy when your current treatment does not control the condition. You will need to take Pregabalin Aristo in addition to your current treatment. Pregabalin Aristo is not used as a single treatment but must always be used in combination with other antiepileptic treatments.

Generalised Anxiety Disorder:Pregabalin Aristo is used in the treatment of Generalised Anxiety Disorder (GAD). The symptoms of Generalised Anxiety Disorder are excessive and prolonged anxiety and worry that are difficult to control. Generalised Anxiety Disorder can also cause restlessness or a feeling of being on edge, easy fatigue (tiredness), difficulty concentrating or memory lapses, irritability, muscle tension or sleep disturbances.
These conditions are different from the stress and strains of everyday life.

2. What you need to know before taking Pregabalin Aristo

Do not take Pregabalin Aristo
If you are allergic to pregabalin or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Pregabalin Aristo.

• In some patients taking pregabalin, symptoms indicative of allergic reactions have been reported. These symptoms include swelling of the face, lips, tongue and throat, as well as a widespread skin rash. If any of these reactions occur, you should contact your doctor immediately.
• Pregabalin Aristo has been associated with dizziness and drowsiness which may increase the incidence of accidental injuries (falls) in elderly patients. Consequently, you should be careful until you have become familiar with the effects the medicine may have on you.
• Pregabalin Aristo can cause blurred or loss of vision or other visual disturbances, many of which are transient. If you experience any visual disturbance you should contact your doctor immediately.
• In some patients with diabetes who gain weight during treatment with pregabalin, it may be necessary to adjust your diabetes medications.
• Some undesirable effects, such as drowsiness, may be more common because patients with spinal cord injury may be treated with other medicines to treat, for example, pain or spasticity, which have undesirable effects similar to those of pregabalin and the severity of these effects may increase if these drugs are taken together.
• Heart failure has been reported in some patients treated with pregabalin; these patients were mostly elderly with cardiovascular disease. Before takingthis medicine you must inform your doctor if you have a history of heart disease.
• Renal failure has been reported in some patients treated with pregabalin. If you notice a reduction in urination during treatment with Pregabalin Aristo, you should inform your doctor as discontinuation of the medicine may improve this condition.
• A small number of patients treated with antiepileptic drugs such as pregabalin have experienced thoughts of self-harm or suicide. If, at any time, you should have thoughts of this kind, contact your doctor immediately.
• When Pregabalin Aristo is used together with other medicines that can cause constipation (such as some types of painkillers) gastrointestinal problems (e.g. constipation, blocked or paralyzed bowel) may occur. Inform your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking this medicine you should inform your doctor if you have a history of alcohol or drug dependence. Do not take a dose of medicine higher than that prescribed.
• Cases of seizures have been reported during the intake of pregabalin or shortly after its discontinuation. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have been reported in some patients taking pregabalin when suffering from other conditions. Immediately inform your doctor if you have a history of serious medical conditions, including liver or kidney disease.

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

Other medicines and Pregabalin Aristo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Pregabalin Aristo and some other medicines can influence each other (interaction). When
taken with other medicines, Pregabalin Aristo may enhance the undesirable effects observed with these
medicines, including respiratory failure and coma. The intensity of dizziness, drowsiness and
reduced concentration may increase if Pregabalin Aristo is taken together with other
medicinal products containing:
Oxycodone – (used as an analgesic)
Lorazepam – (used for the treatment of anxiety)
Alcohol
Pregabalin Aristo can be taken simultaneously with oral contraceptives.

Pregabalin Aristo with food, beverages and alcohol
The capsules of Pregabalin Aristo can be taken with or without food.
It is advisable not to drink alcohol during treatment with Pregabalin Aristo.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregabalin Aristo should not be taken during pregnancy or breastfeeding unless
otherwise indicated by your doctor. Women of childbearing potential should use an effective
method of contraception.

Driving and operating machinery
Pregabalin Aristo can cause dizziness, drowsiness and reduced concentration. You should not drive,
operate complex machinery or engage in potentially dangerous activities until you have
ascertained whether this medicine alters your ability to perform these activities.

3. How to take Pregabalin Aristo

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.
Your doctor will determine the appropriate dose for you.
Pregabalin Aristo is for oral use only.

Peripheral and central neuropathic pain, epilepsy or Generalised Anxiety Disorder:

• Take the number of capsules prescribed by your doctor.
• The dose, suitable for you and your condition, generally ranges from 150 mg to 600 mg per day.
• Your doctor will tell you to take Pregabalin Aristo two or three times a day. If you take the medicine twice a day, take Pregabalin Aristo once in the morning and once in the evening, more or less at the same time. If you take the medicine three times a day, take Pregabalin Aristo once in the morning, once in the afternoon and once in the evening, more or less at the same time.

If you feel that the effect of Pregabalin Aristo is too strong or too weak, talk to your doctor or pharmacist.
If you are an elderly patient (over 65 years of age), you should take Pregabalin Aristo as normal
unless you have kidney problems.
Your doctor may prescribe you a different dosage and/or a different dose if you have kidney problems.
Swallow the capsule whole with water.
Continue taking Pregabalin Aristo until your doctor tells you to stop the medicine.

If you take more Pregabalin Aristo than you should
Contact your doctor immediately or go to the nearest hospital immediately. Bring the
pack of Pregabalin Aristo capsules with you. You may feel sleepy, confused, agitated and restless,
because you have taken more Pregabalin Aristo than you should have. Adjustments have also been reported.

If you forget to take Pregabalin Aristo
It is important to take Pregabalin Aristo capsules regularly every day at the same time. If you forget to take a dose, take it as soon as you remember unless it is
time to take the next dose. In this case, take the next dose as scheduled. Do not take a
double dose to make up for a missed dose.

If you stop taking Pregabalin Aristo
Do not stop treatment with Pregabalin Aristo unless your doctor has told you to. If
treatment is stopped, this must be done gradually over at least one
week.
You should know that after stopping treatment with Pregabalin Aristo in the short and long term
some undesirable effects may occur. These include sleep disturbances, headache, nausea,
feeling of anxiety, diarrhoea, flu-like symptoms, seizures, nervousness, depression, pain,
sweating and dizziness. These symptoms may occur more frequently or severely if you have
taken Pregabalin Aristo for a longer period of time.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Very commonthat can affect more than 1 in 10 people

• Dizziness.
• Sleepiness.
• Headache.

Commonthat can affect up to 1 in 10 people

• Increased appetite.
• Feeling of euphoria, confusion, disorientation, loss of sexual interest, irritability.
• Attention disorders, clumsiness, impaired memory, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, feeling strange.
• Blurred vision, double vision.
• Vertigo or balance problems, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, abdominal bloating
• Difficulty in erection.
• Swelling of the body, including hands and feet.
• Feeling of drunkenness, gait abnormalities.
• Weight gain.
• Muscle cramps, joint pain, back pain, pain in the limbs.
• Sore throat.

Uncommonthat can affect up to 1 in 100 people

• Loss of appetite, weight loss, low blood sugar levels, high blood sugar levels.
• Altered self-perception, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, altered dreams, panic attacks, apathy, aggression, euphoric mood, mental impairment, difficulty thinking, increased sexual interest, sexual problems, including inability to reach orgasm, delayed ejaculation.
• Changes in vision, abnormalities in eye movement, altered vision including tunnel vision, flashes of light, convulsive movements, reduced reflexes, increased activity, dizziness when standing up, skin sensitivity, loss of taste, burning sensation, tremor during movement, reduced consciousness, loss of consciousness, fainting, increased sensitivity to noises, feeling unwell.
• Dry eyes, eye swelling, eye pain, eye weakness, tearing, eye irritation.
• Irregular heartbeat, increased heart rate, low blood pressure, high blood pressure, change in palpitations, heart failure.
• Flushing, hot flashes.
• Difficulty breathing, sore throat, nasal congestion.
• Increased saliva production, heartburn, loss of sensitivity around the mouth.
• Sweating, rash, chills, fever.
• Muscle contractions, swollen joints, muscle stiffness, pain including muscle pain, neck pain.
• Chest pain.
• Difficulty or pain when urinating, incontinence.
• Weakness, thirst, feeling of tightness in the chest.
• Changes in blood test results and liver function tests (increased blood creatine phosphokinase, increased alanine-aminotransferase, increased aspartate aminotransferase, reduced platelet count, neutropenia, increased creatinine, reduced potassium).
• Hypersensitivity, facial swelling, itching, runny nose, nosebleeds, cough, snoring.
• Painful menstrual cycles.
• Cold hands and feet.

Rarethat can affect up to 1 in 1000 people

• Alteration of smell, sensation of visual field oscillation, altered depth perception, visual brilliance, loss of vision.
• Dilated pupils, strabismus.
• Cold sweats, feeling of constriction in the throat, swollen tongue.
• Inflammation of the pancreas.
• Difficulty swallowing.
• Slowed or reduced body movement.
• Difficulty writing appropriately.
• Increased fluid in the abdomen.
• Presence of fluid in the lungs.
• Convulsions.
• Changes in the electrocardiogram (ECG) corresponding to heart rhythm disorders.
• Muscle damage.
• Breast secretion, abnormal breast growth, breast growth in men.
• Interrupted menstrual cycles.
• Kidney failure, reduced urine volume, urinary retention.
• Reduced white blood cell count.
• Inappropriate behavior.
• Allergic reactions (which may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterized by rash, blisters, skin peeling, and pain).
• Jaundice (yellowing of the skin and eyes).
• .

Very rarethat can affect up to 1 in 10000 people

• Liver failure.
• Hepatitis (inflammation of the liver).

In case of swelling of the face or tongue or if the skin becomes red and blisters begin to form
or skin peeling occurs, you should contact your doctor immediately.
Some side effects, such as drowsiness, may be more common because patients with spinal cord injury
may be treated with other medicines to treat, for example, pain or spasticity, which have side effects similar to those of pregabalin and the severity of these
effects may increase if these drugs are taken together.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Pregabalin Aristo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pregabalin Aristo contains

• The active ingredient is pregabalin. Each hard capsule contains 25 mg ,50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.
• The other ingredients are: Capsule contents: pregelatinized starch, mannitol, talc. Capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172) (only for 75 mg, 100 mg, 200 mg, 225 mg, 300 mg) and yellow iron oxide (E172) (only for 200 mg, 225 mg). Ink: Shellac, black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide (E527)

Description of the appearance of Pregabalin Aristo and package contents
25 mg capsules: White hard capsules, marked with the inscription "25" on the capsule body.
50 mg capsules: White hard capsules, marked with the inscription "50" on the capsule body.
75 mg capsules: White and dark orange hard capsules, marked with the inscription "75" on the body
of the capsule.
100 mg capsules: Dark orange hard capsules, marked with the inscription "100" on the body
of the capsule.
150 mg capsules: White hard capsules, marked with the inscription "150" on the capsule body.
200 mg capsules: Red hard capsules, marked with the inscription "200" on the capsule body.
225 mg capsules: Red hard capsules, marked with the inscription "225" on the capsule body.
300 mg capsules: White and dark orange hard capsules, marked with the inscription "300" on the body
of the capsule.
Pregabalin Aristo is available in a cardboard box containing the appropriate number of blisters
in PVC/aluminum containing:
14, 56 or 100 hard capsules of 25 mg
21, 56 or 100 hard capsules of 50 mg
14, 56 or 100 hard capsules of 75 mg
21, 84 or 100 hard capsules of 100 mg
14, 56 or 100 hard capsules of 150 mg
21, 84 or 100 hard capsules of 200 mg
56 or 100 hard capsules of 225 mg
56 or 100 hard capsules of 300 mg
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Straβe 8-10
13435 Berlin
Germany

Distributor for sales
Aristo Pharma Italy S.r.l.
Strada Milanofiori Str. 6 Palazzo n. 3,
20089 Rozzano (MI)

Manufacturer:
Pharmathen International S.A
Industrial Park Sapes,
RodopiPrefecture, Block No 5,
Rodopi 69300
Greece
Aristo Pharma GmbH
Wallenroder Straβe 8-10
13435 Berlin
Germany
PHARMATHEN S.A.
Dervenakion 6
Pallini 15351
Attikis Greece
This medicinal product is authorised in the Member States of the European Economic Area under the following
names: