PREGAGAMMA 75 mg. 30 capsules

What is Pregagamma and what it is used
Pregagamma belongs to a group of medicines used to treat epilepsy, neuropathic pain and generalized anxiety disorder (GAD) in adults.
Peripheral and central neuropathic pain: Pregagamma 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 sensation of tingling, pricking with 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: Pregagamma used to treat some forms of epilepsy (partial onset seizures with or without secondary generalization) in adults. Your doctor will prescribe Pregagamma to help you treat your epilepsy when your current treatment is not controlling your condition. You should take Pregagamma addition to your current treatment. Pregagamma is not intended for private use and should always be used in combination with other antiepileptic treatment.
Generalised Anxiety Disorder: Pregagamma used to treat generalized anxiety disorder (GAD). Symptoms of GAD are prolonged excessive anxiety and worry that are difficult to control. GAD can also cause restlessness or feeling agitated or restless, easily weary, 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 Pregagamma
Do not take Pregagamma:
if you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Warnings and Precautions
Some patients taking Pregagamma have reported symptoms suggesting an 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;
The use of Pregagamma 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 the medicine;
Pregagamma may 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 drowsiness may be more frequent, because patients with spinal cord injury may be taking other medicines to treat such pain or muscle spasm that have similar side effects to Pregabalin and the severity of these effects may increase when co-administered;
There are reports of heart failure in some patients taking Pregagamma; these patients were mostly elderly with cardiovascular damage. 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 Pregagamma. If you notice decreased urination while taking Pregagamma should tell your doctor as stopping the medicine may improve this situation;
A small number of people being treated with antiepileptic drugs such Pregagamma have had thoughts of harming or killing themselves. If you have these thoughts, immediately contact your doctor;
Pregagamma when taken with other drugs that can cause constipation (such as some types of pain relievers), there may occur some gastrointestinal problems (eg. Constipation, blockage or paralysis of the bowel). 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 during intake Pregagamma or shortly after discontinuation of Pregagamma. If you get convulsion, tell your doctor immediately;
Cases of impairment of brain function (encephalopathy) in some patients taking Pregagamma 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
Safety and efficacy in children and adolescents (under 18 years) have not been established and therefore, pregabalin should not be used in this age group.

Other medicines and Pregagamma
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
Pregagamma and certain other medicines can affect each other (interaction). When taken with certain other medicines Pregagamma may intensify the side effects seen with these medicines, including respiratory failure and coma. The degree of dizziness, sleepiness and decreased concentration may be increased if Pregagamma be taken with medicines containing:
Oxycodone - (used as a tool against pain);
Lorazepam - (used for the treatment of anxiety);
Alcohol.
Pregagamma can be taken with oral contraceptives.

Pregagamma with food, drinks and alcohol
Pregagamma capsules can be taken with or without food.
It is recommended not to drink alcohol while taking Pregagamma.

Pregnancy and lactation
Pregagamma 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
Pregagamma can cause dizziness, sleepiness and decreased 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.

Pregagamma contains lactose monohydrate
If your doctor has informed you have an intolerance to some sugars, contact him before taking this medicine.

3. How to take Pregagamma
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.
Pregagamma is intended for oral administration.

Peripheral and central neuropathic pain, epilepsy or Generalised Anxiety Disorder:
Take the number of capsules as instructed by your doctor.
The dose for you and your condition, will generally be between 150 mg and 600 mg each day.
Your doctor will tell you to take Pregagamma or twice or three times daily. The twice a day take Pregagamma daily morning and evening at about the same time. In tid take Pregagamma daily morning, afternoon and evening at about the same time.
If you feel that the effect of Pregagamma is too strong or too weak, talk to your doctor or pharmacist.
If you are an elderly patient (over 65 years) should take Pregagamma 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 Pregagamma until your doctor tells you to stop.

If you take more than the amount Pregagamma
Immediately call your doctor or the nearest hospital emergency room. Take your box or bottle of capsules Pregagamma you. You may feel sleepy, confused, agitated or restless as a result of taking more than the amount Pregagamma.

If you forget to take Pregagamma
It is important to take your Pregagamma 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 Pregagamma
Do not stop taking Pregagamma unless your doctor has told you to do this. Discontinuation of treatment should be done gradually for at least a week.
You should know that after stopping long and short-term treatment with Pregagamma 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 taken Pregagamma 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
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;
High mood, confusion, disorientation, decreased sexual interest, irritability;
Disturbance in attention, clumsiness, memory impairment, memory loss, tremors, difficulty speaking, tingling, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation;
Blurred vision, double vision;
Dizziness, problems with balance, fall;
Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloating;
Erection difficulties;
Swelling of the body, including the extremities;
Inebriation, impaired gait;
Accumulation of body 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;
Changing the 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 the inability to reach orgasm, delayed ejaculation;
Changes in vision, abnormal 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 motion, depressed level of consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise;
Dry eyes, eye swelling, eye pain, weak eyes, watery, eye irritation;
Abnormal heart rhythm, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure;
Flushing, hot flush;
Difficulty breathing, dry nose, nasal congestion;
Increased production of saliva, heartburn, numbness around the lips;
Sweating, rash, chills, fever;
Muscle twitching, joint swelling, muscle stiffness, pain, including muscle pain, neck pain;
Chest pain;
Difficult 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 aspartate aminotransferase, decreased platelet count, neutropenia, increased blood creatinine, decreased potassium levels in the blood);
Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, coughing, snoring;
Painful menstruation;
Cold hands and feet.
Rare: may affect up to 1 in 1,000 people:
Altered sense of 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 movement of the body;
Difficulty in writing;
Increased amount of fluid in the abdomen;
Fluid in the lungs;
seizures;
Changes in recording 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, decreased amount of urine, urinary retention;
A decrease in white blood cells;
Irrational behavior;
Allergic reactions (which may include shortness of breath, inflammation of the eye (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 is red and begin to appear blistering or peeling, you should seek immediate medical advice.

Certain side effects, such as drowsiness may be more frequent, because patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity, that have similar side effects to Pregabalin and the severity of these effects may increase when co-administered.

5. How to store Pregagamma
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and blister 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 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 Pregagamma
The active substance is pregabalin. Each hard capsule contains 75 mg of pregabalin.
The other ingredients are lactose monohydrate, maize starch, talc (E553b), gelatin, titanium dioxide (E171), red iron oxide (E172) and black ink (which contains shellac, black iron oxide (E172), propylene glycol, potassium hydroxide) .

Pregagamma looks like and contents of the pack
Hard capsules, size 4, with brownish red cap and white body, marked "75" on the body with black ink. The capsules contain white to off-white powder.
Pregagamma 75 mg hard capsules are available in PVC / aluminum blister packs containing 10, 14, 20, 21, 28, 30, 56, 60, 70, 84, 90, 100 or 84 (multi-pack: 2 x 42), 112 ( multi-pack: 2 x 56), 120 (multi-pack: 2 x 60), 200 (multi-pack: 2 x 100) hard capsules.
Not all pack sizes may be marketed.

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