Pregabalin Teva Italia

Package Leaflet: Information for the User

Pregabalin Teva Italia 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

Pregabalin
Generic medicine
Please 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 could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or
pharmacist. See section 4.
Contents of this leaflet:
What Pregabalin Teva Italia is and what it is used for
What you need to know before taking Pregabalin Teva Italia
How to take Pregabalin Teva Italia
Possible side effects
How to store Pregabalin Teva Italia
Contents of the pack and other information
What Pregabalin Teva Italia is and what it is used for
Pregabalin Teva Italia belongs to a group of medicines used to treat epilepsy, neuropathic pain, and Generalized Anxiety Disorder (GAD) in adults.
Peripheral and central neuropathic pain: Pregabalin Teva Italia is used to treat chronic pain caused by nerve damage. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes zoster.
Pain sensations may be described as warmth, burning, throbbing, stabbing, shooting, sharp pains, cramps, discomfort, tingling, numbness, paresthesia. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, and fatigue (tiredness), and may impact physical and social activity and overall quality of life.
Epilepsy: Pregabalin Teva Italia is used to treat certain types of epilepsy in adults (partial seizures with or without secondary generalization). Your doctor will prescribe Pregabalin Teva Italia to help manage your epilepsy when your current treatment does not adequately control your condition. You will need to take Pregabalin Teva Italia in addition to your existing treatment. Pregabalin Teva Italia is not used alone but must always be used in combination with other antiepileptic treatments.
Generalized Anxiety Disorder: Pregabalin Teva Italia is used to treat Generalized Anxiety Disorder (GAD). Symptoms of Generalized Anxiety Disorder are characterized by excessive and prolonged anxiety and worry that are difficult to control. Generalized Anxiety Disorder may also cause restlessness or a feeling of tension or being on edge, easy fatigue (tiredness), difficulty concentrating or memory lapses, irritability, muscle tension, or sleep disturbances. These conditions are different from everyday stress and pressures.
What you need to know before taking Pregabalin Teva Italia
Do not take Pregabalin Teva Italia
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 Teva Italia
In some patients treated with pregabalin, symptoms indicating allergic reactions have been reported. These symptoms include swelling of the face, lips, tongue, and throat, as well as widespread skin rash. If you experience any of these reactions, contact your doctor immediately.
Pregabalin has been associated with dizziness and drowsiness, which may increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become familiar with the effects this medicine may have on you.
Pregabalin may cause blurred vision or vision loss or other visual disturbances, many of which are transient. If you experience any visual disturbances, contact your doctor immediately.
In some diabetic patients who gain weight during treatment with pregabalin, it may be necessary to adjust ongoing diabetes therapy.
Some side effects, such as drowsiness, may be more common in patients with spinal cord injury, as these patients may be taking other medicines to treat, for example, pain or spasticity, which have similar side effects to pregabalin, and the severity of these effects may increase when these medicines are taken together.
Cases of heart failure have been reported in some patients treated with pregabalin; most of these patients were elderly with cardiovascular disease. If you have a history of cardiovascular disease before starting treatment with this medicine, inform your doctor.
Cases of renal failure have been reported in some patients treated with pregabalin. If you notice a reduction in urine output during treatment with Pregabalin Teva Italia, inform your doctor, as discontinuing this medicine may improve the condition.
A small number of patients treated with antiepileptic medicines such as pregabalin have experienced suicidal thoughts and self-harming behavior. If you experience such thoughts at any time, contact your doctor immediately.
If Pregabalin Teva Italia is taken with other medicines that can cause constipation (such as certain types of pain medicines), 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, inform your doctor if you have a history of alcohol or medicine abuse or dependence. Do not take a dose higher than prescribed.
Seizures have been reported when taking pregabalin or shortly after discontinuation. If seizures occur, contact your doctor immediately.
Cases of reduced brain function (encephalopathy) have occurred in some patients taking pregabalin when they have other conditions. Inform your doctor if you have a history of other 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 Teva Italia must not be used in this age group.
Other medicines and Pregabalin Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregabalin Teva Italia and other medicines may interact with each other. When Pregabalin Teva Italia is taken together with other medicines that have sedative effects (including opioids), these effects may be enhanced, potentially leading to respiratory failure, coma, and death.
The intensity of dizziness, drowsiness, and reduced concentration may increase if Pregabalin Teva Italia is taken together with other medicines containing:

• Oxycodone - (used as an analgesic)
• Lorazepam - (used for the treatment of anxiety)
• Alcohol

Pregabalin Teva Italia can be taken together with oral contraceptives.
Pregabalin Teva Italia with food, drinks, and alcohol
Pregabalin Teva Italia can be taken with or without food.
It is recommended NOT to drink alcohol during treatment with Pregabalin Teva Italia.
Pregnancy and breastfeeding
Pregabalin Teva Italia must NOT be taken during pregnancy or breastfeeding unless your doctor has advised otherwise. Women of childbearing potential must use an effective method of contraception.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Pregabalin Teva Italia may cause dizziness, drowsiness, and reduced concentration. You must NOT drive, operate complex machinery, or engage in potentially hazardous activities until you are certain this medicine does not impair your ability to perform such activities.
How to take Pregabalin Teva Italia
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose for you.
Pregabalin Teva Italia is for oral use only.
Peripheral and central neuropathic pain, epilepsy, or Generalized Anxiety Disorder:
Take the number of capsules prescribed by your doctor.
The appropriate dose for you and your condition generally ranges between 150 mg and 600 mg per day.
Your doctor will instruct you to take Pregabalin Teva Italia twice or three times daily. If you take the medicine twice daily, take Pregabalin Teva Italia once in the morning and once in the evening, approximately at the same time each day. If you take the medicine three times daily, take Pregabalin Teva Italia 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 Teva Italia is too strong or too weak, discuss this with your doctor or pharmacist.
If you are elderly (over 65 years of age), you should normally take Pregabalin Teva Italia unless you have kidney problems.
Your doctor may prescribe a different dosing regimen and/or a different dose if you have kidney problems.
Swallow the capsule whole with water.
Continue taking Pregabalin Teva Italia until your doctor tells you to stop.
If you take more Pregabalin Teva Italia than you should
Contact your doctor immediately or go immediately to the nearest hospital. Bring the pack of Pregabalin Teva Italia capsules with you. You may feel drowsy, confused, agitated, and restless because you have taken more Pregabalin Teva Italia than you should. Seizures have also been reported.
If you forget to take Pregabalin Teva Italia
It is important to take Pregabalin Teva Italia 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 almost time for your next dose. In this case, take the next dose as scheduled. DO NOT take a double dose to make up for the missed dose.
If you stop taking Pregabalin Teva Italia
DO NOT stop treatment with Pregabalin Teva Italia unless your doctor tells you to. If treatment is to be stopped, it should be discontinued gradually over at least 1 week.
You should be aware that after stopping long-term or short-term treatment with Pregabalin Teva Italia, some side effects may occur. These include sleep disturbances, headache, nausea, anxiety, diarrhea, flu-like symptoms, seizures, restlessness, depression, pain, sweating, and dizziness. These symptoms may occur more frequently or severely if you have taken Pregabalin Teva Italia for a longer period.
If you have any questions about using this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine 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
Feeling of excitement, confusion, disorientation, loss of libido, irritability
Attention disorders, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, feeling strange
Blurred vision, double vision
Vertigo, balance disorders, falls
Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, abdominal distension
Erectile dysfunction
Body swelling, including hands and feet
Feeling of drunkenness, gait abnormalities
Weight gain
Muscle cramps, 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 levels, high blood sugar levels
Altered self-perception, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, altered dreams, panic attacks, apathy, aggression, elevated mood, mental impairment, difficulty thinking, increased sexual desire, sexual problems, including inability to reach orgasm, delayed ejaculation
Visual disturbances, eye movement abnormalities, visual changes including tunnel vision, light flashes, jerky movements, reduced reflexes, increased activity, dizziness in upright position, skin sensitivity, loss of taste, burning sensation, movement tremor, reduced consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell
Dry eyes, eye swelling, eye pain, eye weakness, eye tearing, eye irritation
Heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, heart rate changes, heart failure
Flushing, hot flushes
Breathing difficulties, dry nose, nasal congestion
Increased saliva production, heartburn, loss of sensitivity around the mouth
Sweating, rash, chills, fever
Muscle spasms, joint swelling, muscle stiffness, pain including muscle pain, neck pain
Breast pain
Difficulty or painful urination, incontinence
Weakness, thirst, chest tightness
Changes in blood test results and liver function tests (increased serum creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, reduced platelet count, neutropenia, increased serum creatinine, decreased blood potassium)
Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring
Painful menstruation
Cold hands and feet
Rare: may affect up to 1 in 1,000 people:
Altered sense of smell, visual disturbances, altered depth perception, visual brightness, vision loss
Dilated pupils, strabismus
Cold sweats, throat tightness, tongue swelling
Pancreatitis
Swallowing difficulties
Slowed or reduced body movement
Difficulty writing properly
Increased abdominal fluid
Pulmonary edema
Seizures
Electrocardiogram (ECG) changes corresponding to heart rhythm disorders
Muscle damage
Breast discharge, abnormal breast growth, breast enlargement in men
Interrupted menstrual cycles
Renal failure, reduced urine volume, urinary retention
Reduced white blood cell count
Inappropriate behavior
Allergic reactions (which may include breathing difficulties, eye inflammation (keratitis), and a severe allergic reaction characterized by rash, blisters, skin peeling, and pain)
Jaundice (yellowing of the skin and eyes)
Very rare: may affect up to 1 in 10,000 people:
Liver failure
Hepatitis (liver inflammation)
If you experience swelling of the face or tongue, or if your skin turns red and blisters start to form, or if skin peeling occurs, contact your doctor immediately.
Some side effects, such as drowsiness, may be more common in patients with spinal cord injury, as these patients may be taking other medicines (to treat, for example, pain or spasticity) that have similar side effects to Pregabalin, and the severity of these effects may increase when these medicines are taken together.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at: 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 Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, carton, or bottle.
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 no longer required. This will help protect the environment.

Package contents and other information

What Pregabalin Teva Italia 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: mannitol, pregelatinized maize starch, talc, titanium dioxide (E171), gelatin, yellow iron oxide (E172) (capsules 25, 50, 75, 150, 225, and 300 mg), red iron oxide (E172) (capsules 75, 100, 200, 225, and 300 mg), and black ink (containing shellac, propylene glycol, strong ammonia solution, black iron oxide (E172), and potassium hydroxide).

Description of the appearance of Pregabalin Teva Italia and package contents
Pregabalin Teva Italia 25 mg are opaque ivory-colored hard gelatin capsules marked with the number "25" in black ink on the body of the capsule.
Pregabalin Teva Italia 50 mg are opaque ivory-colored hard gelatin capsules with a radial black band on the cap and the number "50" printed in black, and a radial black band on the body of the capsule.
Pregabalin Teva Italia 75 mg are opaque hard gelatin capsules with a pink cap and ivory body, marked with the number "75" in black ink.
Pregabalin Teva Italia 100 mg are opaque pink-colored hard gelatin capsules marked with the number "100" printed in black on the body of the capsule.
Pregabalin Teva Italia 150 mg are opaque ivory-colored hard gelatin capsules marked with the number "150" in black ink on the body of the capsule.
Pregabalin Teva Italia 200 mg are opaque flesh-colored hard gelatin capsules marked with the number "200" in black ink on the body of the capsule.
Pregabalin Teva Italia 225 mg are opaque hard gelatin capsules with a flesh-colored cap and ivory body, marked with the number "225" in black ink.
Pregabalin Teva Italia 300 mg are opaque hard gelatin capsules with a pink cap and ivory body, marked with the number "300" in black ink.

For 25 mg capsules:
Pregabalin Teva Italia capsules are packaged in PVC-aluminum blisters or unit-dose divisible blisters containing 14, 14x1, 21, 21x1, 50x1, 56, 56x1, 60, 84, 84x1, 90, 100, or 100x1 capsules.

For 50 mg capsules:
Pregabalin Teva Italia capsules are packaged in PVC-aluminum blisters or unit-dose divisible blisters containing 14, 21, 21x1, 56, 56x1, 60, 84, 84x1, 100, or 100x1 capsules.

For 75 mg capsules:
Pregabalin Teva Italia capsules are packaged in PVC-aluminum blisters or unit-dose divisible blisters containing 14, 14x1, 50x1, 56, 56x1, 60, 70, 90, 100, or 100x1 capsules.
Additionally, Pregabalin Teva Italia capsules are packaged in HDPE bottles with PP closure containing 200 capsules.

For 100 mg capsules:
Pregabalin Teva Italia capsules are packaged in PVC-aluminum blisters or unit-dose divisible blisters containing 14, 21, 21x1, 56, 56x1, 84, 84x1, 100, or 100x1 capsules.

For 150 mg capsules:
Pregabalin Teva Italia capsules are packaged in PVC-aluminum blisters or unit-dose divisible blisters containing 14, 14x1, 50x1, 56, 56x1, 60, 90, 100, 100x1, 168, 168x1, or 200x1 capsules.
Additionally, Pregabalin Teva Italia capsules are packaged in HDPE bottles with PP closure containing 200 capsules.

For 200 mg capsules:
Pregabalin Teva Italia capsules are packaged in PVC-aluminum blisters or unit-dose divisible blisters containing 14, 21, 21x1, 84, 84x1, 100, or 100x1 capsules.

For 225 mg capsules:
Pregabalin Teva Italia capsules are packaged in PVC-aluminum blisters or unit-dose divisible blisters containing 14, 14x1, 56, 56x1, 60, 100, or 100x1 capsules.
Additionally, Pregabalin Teva Italia capsules are packaged in HDPE bottles with PP closure containing 200 capsules.

For 300 mg capsules:
Pregabalin Teva Italia capsules are packaged in PVC-aluminum blisters or unit-dose divisible blisters containing 14, 14x1, 50x1, 56, 56x1, 60, 84, 84x1, 90, 100, 100x1, 168, 168x1, or 200x1 capsules.
Additionally, Pregabalin Teva Italia capsules are packaged in HDPE bottles with PP closure containing 200 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 – Milan
Italy

Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25, Zagreb
Croatia
Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren
Germany

This medicine is authorized in the European Economic Area countries under the following names:
Austria: Pregabalin ratiopharm
Finland: Pregabalin ratiopharm
Germany: Pregabalin AbZ
Italy: Pregabalin Teva Italia
Portugal: Pregabalina ratiopharm