Pregabalin Sandoz 75 mg. 56 capsules

What Pregabalin Sandoz and what is it used for?
Pregabalin Sandoz belongs to the group of medicines used to treat epilepsy, neuropathic pain and generalized anxiety disorder (GAD) in adults.
Peripheral and central neuropathic pain: Pregabalin Sandoz is used to treat persistent pain caused by nerve damage. Different diseases can cause peripheral neuropathic pain, such as diabetes or shingles. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, stinging, tingling sensations, pins and needles.
Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue (tiredness), and can affect the physical and social functioning and quality of life in general.
Epilepsy: Pregabalin Sandoz is used to treat some forms of epilepsy (partial onset seizures with or without secondary generalization) in adults. Your doctor will prescribe Pregabalin Sandoz, to help treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin Sandoz in addition to your current treatment. Pregabalin Sandoz is not intended for private use only and should always be used in combination with other antiepileptic treatment.
Generalized anxiety disorder: Pregabalin Sandoz is used for the treatment of generalized anxiety disorder (GAD). The symptoms of GAD are prolonged excessive anxiety and worry that are difficult to control. GAD can also cause restlessness or feeling agitated or restless, tiring easily, having difficulty concentrating or mind going blank, feeling irritable, having muscle tension or sleep problems. This is different from the stress and strains of everyday life.
2. What you need to know before taking Pregabalin Sandoz?
Do not take Pregabalin Sandoz:
If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Warnings and Precautions
Consult your doctor or pharmacist before taking Pregabalin Sandoz.
• Some patients taking Pregabalin Sandoz, reported symptoms, allergic reaction. These symptoms include swelling of the face, lips, tongue and throat, as well as extensive skin rash. If you experience any of these reactions, you should immediately contact your doctor.
• Use of Pregabalin Sandoz is associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients.
Therefore, you should be careful until you get used to any effect of the drug.
• Pregabalin Sandoz can cause blurring or loss of vision or other vision changes, many of which are temporary. You should immediately contact your doctor if you experience changes in your vision.

Some patients with diabetes who gain weight while taking pregabalin may need an alteration in their diabetic medicines.
• Certain side effects such as somnolence, can be more common, because patients with spinal cord injury may be taking other drugs to treat, for example, pain or spasticity, that have similar side effects to Pregabalin and the severity of these effects may grow, when taken
simultaneously.
• There are reports of heart failure in some patients taking Pregabalin Sandoz; these patients were mostly elderly with cardiovascular impairment. Before taking this medication, tell your doctor if you have a history of heart disease.
• There have been reports of kidney failure in some patients taking Pregabalin Sandoz. If you notice decreased urination, while taking Pregabalin Sandoz, you should tell your doctor as stopping the medicine may improve this condition.
• A small number of people being treated with antiepileptic drugs such as Pregabalin Sandoz, have had thoughts of harming or killing themselves. If you have these thoughts, immediately contact your doctor.
• When Pregabalin Sandoz is administered with other drugs that may cause constipation (such as some types of pain relievers), it is possible to occur some gastrointestinal problems (eg. Constipation, a blockage or paralysis of the gut). Tell your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking this medicine you should tell your doctor if you suffer from alcoholism or any drug abuse or dependence. Do not take more medicine than prescribed.
• Cases of convulsions while taking pregabalin Sandoz or shortly after discontinuation of pregabalin Sandoz. If you get a cramp, tell your doctor immediately.
• Cases of impairment of brain function (encephalopathy) in some patients taking Pregabalin Sandoz and suffering from other diseases. Tell your doctor if you have a history of any serious diseases, including liver or kidney disease.
Children and adolescents
The safety and efficacy in children and adolescents (age under 18 years) has not been established and therefore, pregabalin should not be used in this age group.
Other medicines and Pregabalin Sandoz
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
Pregabalin Sandoz and certain other drugs may influence each other (interaction).
When taken with certain other drugs Pregabalin Sandoz may potentiate the side effects seen with these drugs, including respiratory failure and coma. The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Sandoz is taken together with medicines containing:
Oxycodone - (used as an anti-pain)
Lorazepam - (used to treat anxiety)
alcohol
Pregabalin Sandoz can be taken with oral contraceptives.
Pregabalin Sandoz with food, beverages and alcohol
Pregabalin Capsules Sandoz can be taken with or without food.
It is recommended not to drink alcohol while taking Pregabalin Sandoz.
Pregnancy and lactation
Pregabalin Sandoz should not be taken during pregnancy or breastfeeding unless your doctor tells you otherwise. Women of childbearing potential should use effective contraception. If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Driving and using machines
Pregabalin Sandoz may cause dizziness, drowsiness and reduced concentration. You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.
3. How to take Pregabalin Sandoz?
Always take this medicine exactly as your doctor has told you. If you're not sure, ask your doctor or pharmacist.
Your doctor will determine what dose is appropriate for you.
Pregabalin Sandoz is intended for oral administration.
Peripheral and central neuropathic pain, epilepsy or Generalized Anxiety Disorder:
• Take capsules as instructed by your doctor.
• The dose for you and your condition, will generally be between 150 mg and 600 mg daily.
• Your doctor will tell you to take Pregabalin Sandoz or twice or three times daily.
For twice a day take Pregabalin Sandoz daily morning and evening at about the same time. In tid take Pregabalin Sandoz daily morning, afternoon and evening at about the same time.
If you feel that the effect of pregabalin Sandoz is too strong or too weak, talk to your doctor or pharmacist.
If you are an elderly patient (over 65 years) should take Pregabalin Sandoz normally except if you have kidney problems.
Your doctor may prescribe a different dosing schedule and / or dose if you have kidney problems.
Swallow the capsules whole with water.
Continue taking Pregabalin Sandoz, unless your doctor tells you to stop.
If you take more than the amount of Pregabalin Sandoz
Immediately call your doctor or the nearest hospital emergency room. Take your box or bottle, which were Pregabalin capsules Sandoz with you. You may feel sleepy, confused, agitated or restless as a result of taking more than the amount Pregabalin Sandoz.
If you forget to take Pregabalin Sandoz
It is important to take your Sandoz Pregabalin 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 time for your next dose. In this case, just carry on with the next dose as usual. Do not take a double dose to make up the missed dose.
If you stop taking Pregabalin Sandoz
Do not stop taking Pregabalin Sandoz, unless your doctor has told you to do this. Discontinuation of treatment should be done gradually for at least one week you should know that after stopping long and short-term treatment with pregabalin Sandoz may experience certain side effects. These include sleep problems, headaches, nausea, anxiety, diarrhea, flu-like symptoms, convulsions, nervousness, depression, pain, sweating and dizziness. These symptoms may occur more frequently or severely if you have been taking Pregabalin Sandoz for a longer period of time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
As with all drugs, this drug may cause side effects, although not everyone 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
• Increased mood, confusion, disorientation, decreased sexual interest, irritability
• disorders of attention, clumsiness, memory impairment, memory loss, tremors, difficulty speaking, tingling, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation
• Blurred vision, double vision
• Vertigo, problems with balance, fall
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloating
• Difficulty erection
• Swelling of the body, including the extremities
• intoxication, abnormal gait
• Gaining weight
• Muscle cramps, joint pain, back pain, pain in extremity
• Sore throat
Uncommon: may affect up to 1 in 100 people:
• Loss of appetite, weight loss, low blood sugar, high blood sugar
• Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attacks, apathy, aggression, elevated mood, mental disorder, difficulty thinking, increased sexual interest, problems with sexual function, including an inability to achieve orgasm or delayed ejaculation
• Changes in eyesight, unusual eye movements, changes in vision including tunnel vision, flashes of light, convulsive movements, depressed reflexes, increased activity, dizziness on standing, increased skin sensitivity, loss of taste, burning, shaking movement , depressed level of consciousness, loss of consciousness,
fainting, increased sensitivity to noise, malaise
• Dry eyes, eye swelling, eye pain, weak eyes, watery, eye irritation
• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, heart rate changes, cardiac failure
• Flushing, hot flushes
• Difficulty breathing, dry nose, nasal congestion
• Salivary hypersecretion, burning in the heart area, tingling of the lips, fever
• Sweating, rash, chills
• Muscle twitching, joint swelling, muscle stiffness, pain, including muscle pain, neck pain
• Chest Pain
• Difficulty or painful urination, urinary incontinence
• Weakness, thirst, chest tightness
• Changes in the results of blood and liver tests (increased creatinine phosphokinase increased, alanine aminotransferase increased Aspartic
Rare: may affect up to 1 in 1000 people:
• Edited smell, unstable vision, altered depth perception, visual brightness, loss of vision
• dilated pupils, strabismus
• Cold sweat, throat tightness, swelling of the tongue
• Inflammation of the pancreas
• Difficulty swallowing
• Delayed or limited body movement
• Difficulty in writing
• Increased amount of fluid in the abdomen
• Fluid in the lungs
• Seizures
• Changes in the recording of the electrical activity of the heart (ECG), corresponding to heart rhythm disturbances
• Muscle damage
• breast discharge, abnormal breast enlargement, breast enlargement in men
• Disruption of the menstrual cycle
• Renal failure, a reduced amount of urine, urinary retention.
• Reduction of the number of white blood cells
• Inadequate behavior
• Allergic reactions (which may include difficulty in breathing, eye inflammation (keratitis), and serious skin reaction, characterized by rash, blisters, skin peeling and pain)
If you have swelling of the face or tongue or if your skin turns red and begin to appear blistering or peeling, you should seek immediate medical advice.
Certain side effects such as somnolence, can be more common, because patients with spinal cord injury may be taking other drugs to treat, for example, pain or spasticity, that have similar side effects to Pregabalin and the severity of these effects may be increase when co-administered.
Adverse event reporting
If you get any side effects, contact your doctor or pharmacist.
This includes any possible effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can do your bit for obtaining more information on the safety of this medicine.
5. How to store Pregabalin Sandoz?
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the blister container or carton. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.
HDPE bottles: Use within 6 months after first opening.
Do not dispose of medications in wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Pregabalin Sandoz?
- The active substance is pregabalin. Each 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: corn starch, pregelatinized corn starch, talc, gelatin, titanium dioxide (E 171), yellow iron oxide (E172) (all amounts of the active substance in a dosage unit without 150 mg), red iron oxide (E172) ( all amounts of the active substance in a dosage unit without 50 mg and 150 mg), black iron
oxide (E172) (only 25 mg and 300 mg).
Pregabalin Sandoz is available in the following forms:
PVC / PVDC // Al blister, packed in cardboard box
PVC / PVDC // Al unit dose blisters packed in a cardboard box
Container made of HDPE, PP screw cap, packed in cardboard box
Capsules 25 mg:
Blister packs containing 14, 28, 56, 70, 84, 100 or 120 hard capsules
Unit dose blister packs of 56 x 1, 84 x 1 or 100 x 1 hard capsules
Bottles made of HDPE, containing 200 hard capsules
Capsules 50 mg:
Blister packs containing 14, 21, 28, 56, 84 or 100 hard capsules
Unit dose blisters containing 84 x 1 hard capsules
Bottles made of HDPE, containing 200 hard capsules
Capsules 75 mg:
Blister packs containing 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules
Unit dose blisters containing 14, 56, 84, 100 or 210 (3 x 70) hard capsules
Bottles made of HDPE, containing 100, 200 or 250 hard capsules

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