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What SIRANALEN is and what it is used for
SIRANALEN belongs to a group of medicines used to treat epilepsy, neuropathic pain and generalized anxiety disorder (GAD) in adults. Peripheral and central neuropathic pain: SIRANALEN is used to treat long-term pain caused by nerve damage. Various diseases can cause peripheral neuropathic pain such as diabetes or shingles. The sensations of pain can be described as hot, burning, throbbing, shooting, stabbing, sharp, numbing, severe pain, stinging, tingling sensation, needle stinging. Peripheral and central neuropathic pain may also be associated with mood swings, sleep disturbances, fatigue (fatigue) and may affect physical and social functioning and quality of life in general.
Epilepsy: SIRANALEN is used to treat some forms of epilepsy (partial onset seizures with or without secondary generalization) in adults. Your doctor will prescribe SIRANALEN to help you treat your epilepsy when your treatment does not control your condition. You must take SIRANALEN in addition to your current treatment. SIRANALEN is not intended for use alone, but should always be used in combination with other antiepileptic treatments. Generalized Anxiety Disorder: SIRANALEN is used to treat generalized anxiety disorder (GAD). Symptoms of GTR are prolonged excessive anxiety and worry that are difficult to control. GTR can also cause anxiety or a feeling of excitement or nervousness, easy fatigue, difficulty concentrating or white areas in the memory, feelings of irritability, muscle tension or sleep problems. This is different from the stress and tension of everyday life.
2. What you need to know before you take SIRANALEN
Do not take SIRANAL:
If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6),
Warnings and precautions
Talk to your doctor or pharmacist before taking SIRANAL.
Some patients taking pregabalin have reported symptoms that suggest an allergic reaction. These symptoms include swelling of the face, lips, tongue and throat, as well as an extensive skin rash. If you experience any of these reactions, you should contact your doctor immediately.
The use of pregabalin has been associated with dizziness and drowsiness, which may increase the incidence of accidental injuries (falls) in elderly patients. Therefore, you need to be careful while getting used to any effect that the drug may have.
Pregabalin can cause blurring or loss of vision, or other changes in vision, many of which are temporary. You should contact your doctor immediately if you experience changes in your vision.
Some diabetic patients who experience weight gain with pregabalin may need to change their diabetes medications.
Some side effects such as drowsiness may be more common, as patients with spinal cord injury may be taking other medicines to treat, such as pain or muscle spasms, which have pregabalin-like side effects and the severity of these reactions may be increase when the drugs are taken at the same time
Heart failure has been reported in some patients taking pregabalin; most of these patients are elderly and suffer from cardiovascular damage. You should tell your doctor before taking this medicine if you have a history of heart disease.
Renal failure has been reported in some patients taking pregabalin. If you notice decreased urination while taking SIRANALEN, you should tell your doctor, as stopping taking it may improve this condition.
Few people treated with antiepileptics such as pregabalin have had thoughts of harming or killing themselves. If such thoughts occur at any time during treatment, contact your doctor immediately.
When SIRANALEN is taken with other medicines that can cause constipation (such as some painkillers), some gastrointestinal problems (such as constipation, blockage or paralysis of the gut) may occur. Tell your doctor if you get constipated, especially if you are prone to this problem.
You should tell your doctor before taking this medicine if you have a history of alcoholism or any kind of drug abuse or addiction. Do not take more than the prescribed dose.
Convulsions have been reported with pregabalin or shortly after discontinuation of pregabalin. If you get convulsions, contact your doctor immediately.
Cases of impaired brain function (encephalopathy) have been reported in some patients taking pregabalin when
SIRANALEN contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
SIRANALEN contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per capsule, ie essentially 'sodium-free'. is considered to be sodium-free.
3. How to take SIRANAL
Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.
Your doctor will determine which dose is right for you.
SIRANALEN is for oral use only.
Peripheral and central neuropathic pain, epilepsy or generalized anxiety disorder:
Take as many capsules as your doctor prescribes.
The dose appropriate for you and your condition will usually be between 150 mg and 600 mg each day.
Your doctor will advise you to take SIRANALEN either twice or three times a day. When taken twice, take SIRANALEN once in the morning and once in the evening, at about the same time each day. When taken three times, take SIRANALEN once in the morning, once in the afternoon and once in the evening, at about the same time each day.
Doses lower than 75 mg cannot be achieved with available concentrations of SIRANALEN. Other products are available in concentrations lower than 75 mg. If you have the impression that the effect of SIRANALEN 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 SIRANALEN in the usual way, unless you have kidney problems.
Your doctor may prescribe a different dosing schedule and / or a different dose if you have kidney problems. Swallow the capsule whole with water.
Continue to take SIRANALEN until your doctor tells you to stop.
If you take more SIRANALEN than you should
Contact your doctor immediately or visit the emergency department of the nearest hospital. Take the box of SIRANAL capsules with you. You may feel drowsy, confused, agitated or anxious if you take more SIRANALEN than you should. Seizures have also been reported.
If you forget to take SIRANAL
It is important to take SIRANALEN 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. In this case, just continue with the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you stop taking SIRANALEN
Do not stop taking SIRANALEN unless your doctor tells you to. Discontinuation of treatment should be gradual over a week.
You should be aware that you may experience certain side effects after stopping long-term or short-term treatment with pregabalin. These include: sleep problems, headache, nausea, anxiety, diarrhea, flu-like symptoms, convulsions, nervousness, depression, pain, sweating and dizziness. It is currently unknown whether these symptoms are more common or more severe if you have been taking pregabalin for a long 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.
The very common side effects that may affect more than 1 in 10 people are listed below:
Dizziness, drowsiness, headache
Common side effects that may affect up to 1 in 10 people are listed below:
Increased mood, confusion, disorientation, decreased sexual interest, irritability
Attention Deficit Disorder, Clumsiness, Memory Disorders, Memory Loss, Tremor, Speech Difficulty, Tingling, Numbness, Sedation, Lethargy, Insomnia, Fatigue, Abnormal Feeling
Blurred vision, double vision
Vertigo, balance problems, falling
Dry mouth, constipation, vomiting, flatulence, nausea, diarrhea, bloating
Swelling of the body, including the limbs
Intoxication, gait disorders
Muscle cramps, joint pain, back pain, limb pain
Uncommon side effects that may affect up to 1 in 100 people are listed below:
Loss of appetite, weight loss, low blood sugar, high blood sugar.
Changes in self-perception, anxiety, depression, agitation, mood swings, difficulty finding words, hallucinations, pathological dreams, panic attacks, apathy, aggression, high mood, mental impairment, difficulty thinking, increased sexual interest, problems with sexual function, including inability to reach orgasm, delayed ejaculation.
Changes in vision, unusual movement of the eyes
Changes in blood and liver function tests (increased levels of creatinine phosphokinase in the blood, increased levels of alanine aminotransferase, increased levels of aspartate aminotransferase, decreased platelet count, neutropenia, increased blood levels of creatine ).
Hypersensitivity, swelling of the face, itching, hives, runny nose, nosebleeds, cough, snoring.
Cold hands and feet.
Rare side effects that may affect up to 1 in 1,000 people are listed below:
Altered sense of smell, unstable vision, increased perception of depth, visual brightness, loss of vision.
Dilated pupils, squinting.
Cold sweat, tightness in the throat, swelling of the tongue.
Inflammation of the pancreas.
Delayed or limited body movement.
Increased amount of fluid in the abdomen.
Fluid in the lungs.
Changes in the electrical recording of cardiac activity (ECG), which correspond to disturbances in heart rhythm.
Breast secretion, abnormal breast growth, breast growth in men.
Impaired menstrual cycle.
Renal failure, decreased urine output, urinary retention.
Decreased white blood cell count.
Allergic reactions (which may include difficulty breathing, eye inflammation (keratitis) and severe skin reactions characterized by rash, scaling, peeling of the skin and pain).
Jaundice (yellowing of the skin and eyes).
The very rare side effects that may affect up to 1 in 10,000 people are listed below:
Hepatitis (inflammation of the liver)
If you have swelling of the face or tongue, or if your skin becomes red and blisters or flakes appear, you should consult a doctor immediately.
Certain side effects such as drowsiness may be more common, as patients with spinal cord injury may be taking other medicines to treat, such as pain or muscle spasms, which have pregabalin-like side effects and the severity of these reactions may increases when the drugs are taken at the same time.
How to store SIRANAL
Keep out of reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the package and additional information
What SIRANALEN contains
The active substance is pregabalin. Each hard capsule contains 75 mg of pregabalin.
The other ingredients are:
Capsule contents: corn starch, lactose monohydrate, talc.
Capsule body: gelatin, titanium dioxide (E171), sodium lauryl sulphate, purified water.
Capsule cap: gelatin, titanium dioxide (E 171), patent blue V (E131), sodium lauryl sulphate, purified water.
What SIRANALEN looks like and contents of the pack
Blue-white hard gelatin capsules, size "4" (approximate length 14.3 mm), filled with almost white powder.
PVC / A1 and PVC / PVDC / A1 blisters with 14, 21, 30, 56, 84, 100 or 112 capsules. Not all pack sizes may be marketed.
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