Pregabalin Aurobindo: detailed information

Package leaflet: Information for the user

Pregabalin Aurobindo 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules, 225 mg hard capsules, 300 mg hard capsules

Read 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Pregabalin Aurobindo is and what it is used for
What you need to know before taking Pregabalin Aurobindo
How to take Pregabalin Aurobindo
Possible side effects
How to store Pregabalin Aurobindo
Contents of the pack and other information

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

Pregabalin Aurobindo belongs to a group of medicines used to treat epilepsy, neuropathic pain, and Generalized Anxiety Disorder (GAD) in adults.
Central and peripheral neuropathic pain: Pregabalin Aurobindo is used to treat long-lasting pain caused by nerve damage. Neuropathic pain can be caused by various types of diseases, such as diabetes or herpes. Pain sensations may be described as heat, burning, pulsations, electric shocks, stabbing or shooting pain, acute pain, cramps, discomfort, tingling, numbness, or pins and needles. Central and peripheral neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue (tiredness), and may impact physical and social activities and overall quality of life.
Epilepsy: Pregabalin Aurobindo is used in the treatment of a form of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe Pregabalin Aurobindo to help manage your epilepsy when your current treatment is not adequately controlling your condition. You must take Pregabalin Aurobindo in addition to your current treatment. Pregabalin Aurobindo is not intended to be used alone, but must always be used in combination with other antiepileptic treatments.
Generalized Anxiety Disorder: Pregabalin Aurobindo is used to treat Generalized Anxiety Disorder (GAD). Symptoms of GAD include anxiety and excessive, prolonged worry that is difficult to control. GAD may also cause restlessness or a feeling of being keyed up or on edge, easy fatigability (tiredness), difficulty concentrating or mental blanks, irritability, muscle tension, or sleep disturbances. This is a condition distinct from everyday stress and tension.

2. What you need to know before taking Pregabalin Aurobindo

Do not take Pregabalin Aurobindo

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 or pharmacist before taking Pregabalin Aurobindo.

Some patients taking Pregabalin Aurobindo have reported symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as widespread rash. If you experience any of these reactions, you must contact your doctor immediately.
Pregabalin Aurobindo has been associated with dizziness and somnolence, which may increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become accustomed to any effects this medicine may have.
Pregabalin Aurobindo may cause blurred vision or loss of vision, or other changes in vision, many of which are temporary. You must inform your doctor immediately if you experience any changes in vision.
Some diabetic patients who gain weight while taking pregabalin may need to adjust their diabetes medications.
Some side effects, such as somnolence, may be more common because patients with spinal cord injuries may be taking other medicines that have similar side effects to pregabalin (e.g., for pain or spasticity), and the severity of these effects may increase when taken together.
Cases of heart failure have been reported in some patients during treatment with Pregabalin Aurobindo; these patients were mostly elderly patients with cardiovascular conditions. Before taking this medicine, you must inform your doctor if you have a history of heart disease.
Cases of renal failure have been reported in some patients during treatment with Pregabalin Aurobindo. If you notice a decrease in urination while taking Pregabalin Aurobindo, you should inform your doctor, as discontinuation of the medicine may improve this condition.
A small number of people treated with antiepileptic medicines such as Pregabalin Aurobindo have had thoughts of harming themselves or of suicide. If you have such thoughts at any time, contact your doctor immediately.
When Pregabalin Aurobindo is taken together with other medicines that can cause constipation (such as certain types of painkillers), gastrointestinal problems (e.g., constipation, bowel obstruction or paralysis) may occur. Inform your doctor if you experience constipation, especially if you are prone to this problem.
Before taking this medicine, you must inform your doctor if you have a history of alcoholism or of any drug abuse or dependence. Do not take more medicine than prescribed.
Cases of seizures have been reported during treatment with Pregabalin Aurobindo or shortly after discontinuation. If you have a seizure, contact your doctor immediately.
Cases of reduced brain function (encephalopathy) have been reported in some patients taking Pregabalin Aurobindo when they have other underlying conditions. Inform your doctor if you have a history of any serious medical condition, 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 must not be used in this age group.

Other medicines and Pregabalin Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregabalin Aurobindo and other medicines can interact with each other. When Pregabalin Aurobindo is taken with other medicines, it may enhance the adverse effects observed with these medicines, including respiratory failure and coma. The intensity of dizziness, somnolence, and reduced concentration may increase if Pregabalin Aurobindo is taken together with medicines containing:
oxycodone – (used as a painkiller)
lorazepam – (used for the treatment of anxiety)
alcohol
Pregabalin Aurobindo can be taken with oral contraceptives.

Pregabalin Aurobindo with food, drinks and alcohol
Pregabalin Aurobindo capsules can be taken with or without food.
You are advised not to drink alcohol while taking Pregabalin Aurobindo.

Pregnancy, breastfeeding and fertility
Pregabalin Aurobindo must not be taken during pregnancy or breastfeeding, unless your doctor has advised otherwise. Women of childbearing potential must use effective contraception. If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Pregabalin Aurobindo may cause dizziness, somnolence, and reduced concentration. You must not drive, operate complex machinery, or engage in potentially hazardous activities until you have determined how this medicine affects your ability to perform these tasks.

3. How to take Pregabalin Aurobindo

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose for you.
Pregabalin Aurobindo is for oral use only.
Central or peripheral neuropathic pain, epilepsy or Generalized Anxiety Disorder:

Take the number of capsules as prescribed by your doctor.
The dose, which has been adjusted according to your condition, is usually between 150 mg and 600 mg daily.
Your doctor will tell you whether to take Pregabalin Aurobindo two or three times a day. For twice-daily dosing, take Pregabalin Aurobindo once in the morning and once in the evening, approximately at the same time each day. For three times daily, take Pregabalin Aurobindo once in the morning, once in the afternoon, and once in the evening, approximately at the same time each day.

If you feel that the effect of Pregabalin Aurobindo is too strong or too weak, consult your doctor or pharmacist.
If you are an elderly patient (over 65 years of age), you should take Pregabalin Aurobindo as usual, unless you have kidney problems.
If you have kidney problems, your doctor may prescribe a different dosing schedule or dose.
Swallow the capsules whole with water.
Continue taking Pregabalin Aurobindo until your doctor tells you to stop.

If you take more Pregabalin Aurobindo than you should
Call your doctor or go to the nearest hospital emergency department. Take the pack or bottle of Pregabalin Aurobindo capsules with you. After taking more Pregabalin Aurobindo than you should, you may feel drowsy, confused, agitated, or restless.

If you forget to take Pregabalin Aurobindo
It is important to take Pregabalin Aurobindo capsules regularly at the same time each day. If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Pregabalin Aurobindo
Do not stop taking Pregabalin Aurobindo unless your doctor tells you to. If treatment is to be stopped, it should be done gradually over a minimum of 1 week.
After stopping long-term or short-term treatment with Pregabalin Aurobindo, you should be aware that you may experience certain unwanted effects. These include sleep disturbances, headache, nausea, anxiety, diarrhoea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. These symptoms may occur more commonly or be more severe if you have been taking Pregabalin Aurobindo for a longer period.

If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Very common side effects (may affect more than 1 in 10 people):
Dizziness, drowsiness, headache

Common side effects (may affect up to 1 in 10 people):

Increased appetite
Euphoria, confusion, disorientation, reduced sexual interest, irritability
Attention disturbance, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling strange
Blurred vision, double vision
Vertigo, balance problems, falls
Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea and abdominal swelling
Erectile dysfunction
Body swelling including limbs
Feeling of drunkenness, gait abnormalities
Weight gain
Muscle cramps, joint pain, back pain, limb pain
Sore throat

Uncommon side effects (may 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 changes, difficulty finding words, hallucinations, abnormal dreams, panic attacks, apathy, aggression, elevated mood, mental impairment, difficulty thinking, increased sexual interest, sexual function problems including inability to achieve orgasm, delayed ejaculation
Visual disturbances, unusual eye movements, visual alterations including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness upon standing, skin sensitivity, loss of taste, burning sensation, tremor when moving, reduced consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise
Dry eyes, swollen eyes, eye pain, sensitive eyes, watery eyes, eye irritation
Heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, heart rate irregularities, heart failure
Flushing, hot flushes
Breathing difficulties, dry nose, nasal congestion
Increased saliva production, heartburn, numbness around the mouth
Sweating, rash, chills, fever
Muscle spasm, joint swelling, muscle stiffness, pain including muscle pain, neck pain
Difficulty urinating or painful urination, incontinence
Weakness, thirst, chest tightness
Changes in blood and liver test results (increased blood creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, reduced platelet count, neutropenia, increased blood creatinine, reduced blood potassium levels)
Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring
Painful menstruation
Cold hands and feet

Rare side effects (may affect up to 1 in 1,000 people):

Altered sense of smell, sensation of oscillation in the visual field, altered depth perception, visual brightness, vision loss
Dilated pupils, strabismus
Cold sweating, throat tightness, swollen tongue
Pancreatitis
Difficulty swallowing
Slowed or reduced body movement
Difficulty writing properly
Increased fluid in the abdomen
Fluid in the lungs
Seizures
Electrocardiogram (ECG) abnormalities corresponding to heart rhythm disturbances
Muscle damage
Breast discharge, abnormal breast growth, breast growth in men
Disrupted menstrual cycles
Kidney failure, reduced urine volume, urinary retention
Decreased white blood cell count
Inappropriate behaviour
Allergic reactions (which may include breathing difficulties, eye inflammation (keratitis), and a severe skin reaction characterised by rash, blistering, peeling skin, and pain)

If you experience facial or tongue swelling, or if your skin turns red and starts to blister or peel, seek immediate medical attention.

Some side effects, such as drowsiness, may be more common because patients with spinal cord injuries may be taking other medicines that have side effects similar to those of pregabalin, for example to treat pain or spasticity, and the severity of these effects may be increased when taken together.

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pregabalin Aurobindo

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 medicines via wastewater 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 Aurobindo Contains
The active substance is pregabalin.
Each hard capsule contains 25 mg of pregabalin.
Each hard capsule contains 50 mg of pregabalin.
Each hard capsule contains 75 mg of pregabalin.
Each hard capsule contains 100 mg of pregabalin.
Each hard capsule contains 150 mg of pregabalin.
Each hard capsule contains 200 mg of pregabalin.
Each hard capsule contains 225 mg of pregabalin.
Each hard capsule contains 300 mg of pregabalin.

The other components are:
Capsule contents: Maize starch, talc
Capsule shell: Titanium dioxide (E171), gelatin, sodium lauryl sulfate, iron oxide red (E172)
Printing ink: Shellac, propylene glycol, iron oxide black (E172), potassium hydroxide

Description of the Appearance of Pregabalin Aurobindo and Package Contents
Hard capsules.

Pregabalin Aurobindo 25 mg hard capsules
White cap/white body, size “5”, hard gelatin capsule shell, printed with “Z” on the cap and “10” on the body in black ink, containing white to almost white granular powder.

Pregabalin Aurobindo 50 mg hard capsules
White cap/white body, size “4”, hard gelatin capsule shell, printed with “Z” on the cap and “11” on the body in black ink, containing white to almost white granular powder.

Pregabalin Aurobindo 75 mg hard capsules
Orange cap/white body, size “4”, hard gelatin capsule shell, printed with “Z” on the cap and “12” on the body in black ink, containing white to almost white granular powder.

Pregabalin Aurobindo 100 mg hard capsules
Orange cap/orange body, size “3”, hard gelatin capsule shell, printed with “Z” on the cap and “13” on the body in black ink, containing white to almost white granular powder.

Pregabalin Aurobindo 150 mg hard capsules
White cap/white body, size “2”, hard gelatin capsule shell, printed with “Z” on the cap and “14” on the body in black ink, containing white to almost white granular powder.

Pregabalin Aurobindo 200 mg hard capsules
Light orange cap/light orange body, size “1”, hard gelatin capsule shell, printed with “Z” on the cap and “15” on the body in black ink, containing white to almost white granular powder.

Pregabalin Aurobindo 225 mg hard capsules
Light orange cap/white body, size “1”, hard gelatin capsule shell, printed with “Z” on the cap and “16” on the body in black ink, containing white to almost white granular powder.

Pregabalin Aurobindo 300 mg hard capsules
Orange cap/white body, size “0”, hard gelatin capsule shell, printed with “Z” on the cap and “17” on the body in black ink, containing white to almost white granular powder.

Pregabalin Aurobindo hard capsules are available in blister packs made of transparent PVC/aluminum.

Pack sizes:
Blister packs: 14, 21, 56, 84 and 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l. – Via San Giuseppe, 102 – 21047 Saronno (Varese)

Manufacturer Responsible for Batch Release
APL Swift Services (Malta) Limited - HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Milpharm Limited - Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Pregabalin Aurobindo
Portugal: Pregabalina Aurovitas
Spain: Pregabalina Aurovitas 25 mg / 75 mg / 150 mg / 300 mg hard capsules EFG