Drug Ingredient Information
PREGABALIN-75MG+NORTRIPTYLINE-10MG
PREGABALIN
| Information for
patients
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| Drug Information |
PREGABALIN belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.
Peripheral and central neuropathic pain: PREGABALIN is used to treat long lasting pain caused by damage to the nerves. A variety of 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, tingling, numbness, pins and needles. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact on physical and social functioning and overall quality of life.
Epilepsy: PREGABALIN is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe PREGABALIN for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take PREGABALIN in addition to your current treatment. PREGABALIN is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Generalised Anxiety Disorder: PREGABALIN is used to treat Generalised 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 keyed up or on edge, being easily fatigued (tired), having difficulty concentrating or mind going blank, feeling irritable, having muscle tension or sleep disturbance. This is different to the stresses and strains of everyday life. |
| Drug Alert |
| Alert |
if you are allergic (hypersensitive) to pregabalin or any of the other ingredients of Pregabalin. |
| Before Consuming
the Medicine
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| Avoid Drug |
The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore, pregabalin should not be used in this age group.
Some patients taking PREGABALIN have reported symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as diffuse skin rash. Should you experience any of these reactions, you should contact your physician immediately.
PREGABALIN has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients. Therefore, you should be careful until you are used to any effect the medicine might have.
PREGABALIN may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary. You should immediately tell your doctor if you experience any 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 may be more common, such as sleepiness, because patients with spinal cord injury 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 be increased when taken together.
There have been reports of heart failure in some patients when taking Pregabalin; these patients were mostly elderly with cardiovascular conditions. |
| Drug Special Care |
Before taking any new medicine with PREGABALIN you should talk to your doctor. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
PREGABALIN and certain other medicines may influence each other (interaction). When taken with certain other medicines, PREGABALIN may potentiate the side effects seen with these medicines, including respiratory failure and coma. The degree of dizziness, sleepiness and decreased concentration may be increased if PREGABALIN is taken together with medicinal products containing:
Oxycodone – (used as a pain-killer)
Lorazepam – (used for treating anxiety)
Alcohol
PREGABALIN may be taken with oral contraceptives. |
| Drug Drug Interactions |
Before taking any new medicine with PREGABALIN you should talk to your doctor. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
PREGABALIN and certain other medicines may influence each other (interaction). When taken with certain other medicines, PREGABALIN may potentiate the side effects seen with these medicines, including respiratory failure and coma. The degree of dizziness, sleepiness and decreased concentration may be increased if PREGABALIN is taken together with medicinal products containing:
Oxycodone – (used as a pain-killer)
Lorazepam – (used for treating anxiety)
Alcohol
PREGABALIN may be taken with oral contraceptives. |
| Drug Pregnancy Interaction |
Ask your doctor or pharmacist for advice before taking any medicine. PREGABALIN should not be taken during pregnancy, unless you are told otherwise by your doctor. Effective contraception must be used by women of child-bearing potential. Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking PREGABALIN. |
| Drug Breast feeding Interaction |
It is not recommended to breast-feed your baby while using PREGABALIN as it is not known if PREGABALIN may be found in breast milk. Ask your doctor or pharmacist for advice before taking any medicine while breast-feeding. |
| Drug Machinery Interaction |
PREGABALIN may produce dizziness, sleepiness and decreased concentration. You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities. |
| Drug More Information |
PREGABALIN capsules may be taken with or without food.
It is advised not to drink alcohol while taking PREGABALIN |
| How to take the
Medicine
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| Consumption Info |
|
| Drug quanitty |
The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg each day. |
| Drug Dose |
Your doctor will tell you to take PREGABALIN either twice or three times a day. For twice a day take PREGABALIN once in the morning and once in the evening, at about the same time each day. For three times a day take PREGABALIN once in the morning, once in the afternoon and once in the evening, at about the same time each day.
If you have the impression that the effect of PREGABALIN 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 PREGABALIN normally except if you have problems with your kidneys.
Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys.
Swallow the capsule whole with water.
Continue taking PREGABALIN until your doctor tells you to stop. |
| Excess Drug Consumption |
Call your doctor or go to the nearest hospital emergency unit immediately. Take your box or bottle of PREGABALIN capsules with you. You may feel sleepy, confused, agitated or restless as a result of taking more PREGABALIN than you should. |
| Forgot Drug Consumption |
It is important to take your 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 that case, just carry on with the next dose as normal. Do not take a double dose to make up for a forgotten dose. |
| Stop Drug Consumption |
Do not stop taking PREGABALIN unless your doctor tells you to. If your treatment is stopped it should be done gradually over a minimum of 1 week. If you have any further questions on the use of this product, ask your doctor or pharmacist. After stopping long and short-term pregabalin treatment, you need to know that you may experience certain side effects. These include, trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, pain, sweating, and dizziness. It is not clear at this time whether these symptoms occur more commonly or severely if you have been taking pregabalin for a longer period of time. |
| Possible Side
Effects
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| General Information |
Dizziness, tiredness |
| Common Drug Side Effects |
Increased appetite
Feeling of elation, confusion, disorientation, changes in sexual interest, irritability
Disturbance in attention, clumsiness, memory impairment, tremor, difficulty with speaking, tingling feeling, sedation, lethargy, insomnia, fatigue, headache
Blurred vision, double vision
Vertigo, problems with balance
Dry mouth, constipation, vomiting, flatulence
Difficulties with erection
Swelling of the body including extremities
Feeling drunk, abnormal style of walking
Weight gain |
| Rare Drug Side Effects |
Changes in heart beat
Coldness of hands and feet,
Cough, nasal congestion, runny nose, nose bleed, snoring
Abnormal sense of smell, changes in vision including tunnel vision, swinging vision, altered perception of depth, flashes of light, visual brightness
Dilated pupils, cross eyes, eye irritation
Fever, cold sweat, tightness of the throat
Inflammation of the pancreas
Difficulty in swallowing
Slow or reduced movement of the body
Difficulty with writing properly
Hives
Increased fluid in the abdomen
Muscle damage
Neck pain
Breast pain, breast discharge, abnormal breast growth, painful or interrupted menstrual periods
High blood sugar
Weight loss
Elevated mood
Kidney failure, reduced urine volume
Changes in blood test results (decrease in blood potassium, increase in blood creatinine, decrease in white blood cell count including neutrophils)
Inappropriate behaviour
Additional reactions reported from post marketing experience include heart failure, changes in the recording of electrical changes (ECG) in the heart which correspond to heart rhythm disturbances, fluid in the lungs, loss of consciousness, convulsions, hypersensitivity and allergic reactions (which may include swollen face, swollen tongue, difficulty breathing, itchiness, inflammation of the eyes (keratitis), vision loss and a serious skin reaction characterized by rash, blisters, peeling skin and pain), mental impairment, aggression, urinary retention, diarrhoea, nausea, and feeling unwell. |
| Very Rare Drug Side Effects |
Loss of appetite, low blood sugar
Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, loss of memory, hallucinations, abnormal dreams, panic attacks, apathy, feeling abnormal, problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation
Difficulty with thinking, numbness, changes in eyesight, unusual eye movement, jerky movements, reduced reflexes, increased activity, dizziness on standing, sensitive skin, loss of taste, burning sensation, tremor on movement, decreased consciousness, fainting, increased sensitivity to noise
Dry eyes, eye swelling, eye pain, weak eyes, watery eyes
Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure
Flushing, hot flushes
Difficulty breathing, sore throat, dry nose
Swollen abdomen, increased saliva production, heartburn, numb around mouth
Sweating, rash ,chills
Muscle twitching, joint swelling, muscle cramp, muscle stiffness, pain including muscle pain, joint pain, back pain, pain in limb
Difficulty with or painful urination, incontinence,
Weakness, fall, thirst, chest tightness
Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine amino transferase increased,aspartate aminotransferase increased, platelet count decreased) |
| Drug Side Effects Symptoms |
If you experience swollen face or tongue or if your skin turns red and starts to blister or peel you should seek immediate medical advice.
Certain side effects may be more common, such as sleepiness, because patients with spinal cord injury 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 be increased when taken together. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. |
| How to Store the
Medicine
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| How to Store the Medicine |
Keep PREGABALIN out of the reach and sight of children. Do not use PREGABALIN after the expiry date which is stated on the carton or bottle. This medicinal product does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. |
NORTRIPTYLINE
| Information for
patients
|
| Drug Information |
It is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states. |
| Drug Alert |
| Alert |
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| Before Consuming
the Medicine
|
| Avoid Drug |
Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
Not all antidepressant medicines prescribed for children are FDA approved for use in children. |
| Drug Special Care |
Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. |
| Drug Drug Interactions |
Administration of reserpine during therapy with a tricyclic antidepressant has been shown to produce a “stimulating” effect in some depressed patients.
Close supervision and careful adjustment of the dosage are required when nortriptyline hydrochloride is used with other anticholinergic drugs and sympathomimetic drugs.
Concurrent administration of cimetidine and tricyclic antidepressants can produce clinically significant increases in the plasma concentrations of the tricyclic antidepressant. The patient should be informed that the response to alcohol may be exaggerated.
A case of significant hypoglycemia has been reported in a type II diabetic patient maintained on chlorpropamide (250 mg/day), after the addition of nortriptyline (125 mg/day). |
| Drug Pregnancy Interaction |
Safe use of nortriptyline hydrochloride during pregnancy and lactation has not been established; therefore, when the drug is administered to pregnant patients, nursing mothers, or women of childbearing potential, the potential benefits must be weighed against the possible hazards. Animal reproduction studies have yielded inconclusive results. |
| Drug Breast feeding Interaction |
Safe use of nortriptyline hydrochloride during pregnancy and lactation has not been established; therefore, when the drug is administered to pregnant patients, nursing mothers, or women of childbearing potential, the potential benefits must be weighed against the possible hazards. Animal reproduction studies have yielded inconclusive results. |
| Drug Machinery Interaction |
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| Drug More Information |
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| How to take the
Medicine
|
| Consumption Info |
|
| Drug quanitty |
Usual Adult Dose
- 25 mg three or four times daily; dosage should begin at a low level and be increased as required. As an alternative regimen, the total daily dosage may be given once a day. When doses above 100 mg daily are administered, plasma levels of nortriptyline should be monitored and maintained in the optimum range of 50 to 150 ng/mL. Doses above 150 mg/day are not recommended.
Elderly and Adolescent Patients
- 30 to 50 mg/day, in divided doses, or the total daily dosage may be given once a day.
Nortriptyline hydrochloride is not recommended for children. |
| Drug Dose |
Nortriptyline hydrochloride is administered orally. Lower than usual dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients than for hospitalized patients who will be under close supervision. The physician should initiate dosage at a low level and increase it gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission. |
| Excess Drug Consumption |
Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose, therefore, hospital monitoring is required as soon as possible. |
| Forgot Drug Consumption |
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| Stop Drug Consumption |
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| Possible Side
Effects
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| General Information |
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| Common Drug Side Effects |
Included in the following list are a few adverse reactions that have not been reported with this specific drug. However, the pharmacologic similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when nortriptyline is administered.
Cardiovascular
- Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke.
Psychiatric
- Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia, panic, nightmares; hypomania; exacerbation of psychosis.
Neurologic
- Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alteration in EEG patterns; tinnitus.
Anticholinergic
- Dry mouth and, rarely, associated sublingual adenitis; blurred vision, disturbance of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract. Allergic - Skin rash, petechiae, urticaria, itching, photosensitization (avoid excessive exposure to sunlight); edema (general or of face and tongue), drug fever, cross-sensitivity with other tricyclic drugs.
Hematologic
- Bone marrow depression, including agranulocytosis; eosinophilia; purpura; thrombocytopenia.
Gastrointestinal
- Nausea and vomiting, anorexia, epigastric distress, diarrhea, peculiar taste, stomatitis, abdominal cramps, black-tongue.
Endocrine
- Gynecomastia in the male, breast enlargement and galactorrhea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels; syndrome of inappropriate ADH (antidiuretic hormone) secretion.
Other
- Jaundice (simulating obstructive), altered liver function; weight gain or loss; perspiration; flushing; urinary frequency, nocturia; drowsiness, dizziness, weakness, fatigue; headache; parotid swelling; alopecia.
Withdrawal Symptoms
- Though these are not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise. |
| Rare Drug Side Effects |
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| Very Rare Drug Side Effects |
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| Drug Side Effects Symptoms |
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| How to Store the
Medicine
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| How to Store the Medicine |
Store at 20°-25°C (68°-77°F) |
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Substitute Drugs
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