Drug Ingredient Information
PREGABALIN-75MG+METHYLCOBALAMIN-750MCG
PREGABALIN
| Information for
patients
|
| 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
|
| 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
|
| 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
|
| 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
|
| 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. |
METHYLCOBALAMIN
| Information for
patients
|
| Drug Information |
Vitamin B12, is used to treat vitamin B12 deficiency, cyanide poisoning, and hereditary deficiency of transcobalamin II.[3] It is also given as part of the schilling test for detecting pernicious anemia.[3]
For cyanide poisoning, large amount may be given intravenously, and sometimes in combination with sodium thiosulfate.[4] The mechanism of action is straightforward: the hydroxycobalamin hydroxide ligand is displaced by the toxic cyanide ion, and the resulting harmless B12 complex is excreted in urine. In the United States, the Food and Drug Administration approved (in 2006) the use of hydroxocobalamin for acute treatment of cyanide poisoning.[5]
High vitamin B12 level in elderly individuals may protect against brain atrophy or shrinkage, associated with Alzheimer's disease and impaired cognitive function.[6]
High-dose administration of Vitamin B12 has been additionally validated to stimulate the activity of the body's TH1 suppressor T-Cells, which then down-regulates the over-production of the allagen antibody 1gE in allergic individuals. |
| Drug Alert |
| Alert |
no data available |
| Before Consuming
the Medicine
|
| Avoid Drug |
no data available |
| Drug Special Care |
Vitamin B12 supplements in theory should be avoided in people sensitive or allergic to cobalamin, cobalt, or any other product ingredients. However, direct allergy to a vitamin or nutrient is extremely rare, and if reported, other causes should be sought. |
| Drug Drug Interactions |
Aminosalicylic acid (para-aminosalicylic acid, PAS, Paser): Aminosalicylic acid can reduce oral vitamin B12 absorption, possibly by as much as 55%, as part of a general malabsorption syndrome. Megaloblastic changes, and occasional cases of symptomatic anemia have occurred, usually after doses of 8 to 12 g/day for several months. Vitamin B12 levels should be monitored in people taking aminosalicylic acid for more than one month.
Antibiotics: An increased bacterial load can bind significant amounts of vitamin B12 in the gut, preventing its absorption. In people with bacterial overgrowth of the small bowel, antibiotics such as metronidazole (Flagyl) can actually improve vitamin B12 status. The effects of most antibiotics on gastrointestinal bacteria are unlikely to have clinically significant effects on vitamin B12 levels.
Hormonal contraception: The data regarding the effects of oral contraceptives on vitamin B12serum levels are conflicting. Some studies have found reduced serum levels in oral contraceptive users, but others have found no effect despite use of oral contraceptives for up to 6 months. When oral contraceptive use is stopped, normalization of vitamin B12 levels usually occurs. Lower vitamin B12serum levels seen with oral contraceptives probably are not clinically significant.
Chloramphenicol (Chloromycetin): Limited case reports suggest that chloramphenicol can delay or interrupt the reticulocyte response to supplemental vitamin B12 in some patients. Blood counts should be monitored closely if this combination cannot be avoided.
Cobalt irradiation: Cobalt irradiation of the small bowel can decrease gastrointestinal (GI) absorption of vitamin B12.
Colchicine: Colchicine in doses of 1.9 to 3.9 mg/day can disrupt normal intestinal mucosal function, leading to malabsorption of several nutrients, including vitamin B12. Lower doses do not seem to have a significant effect on vitamin B12 absorption after 3 years of colchicine therapy. The significance of this interaction is unclear. Vitamin B12 levels should be monitored in people taking large doses of colchicine for prolonged periods.
Colestipol (Colestid), cholestyramine (Questran): These resins used for sequestering bile acids to decrease cholesterol, can decrease gastrointestinal (GI) absorption of vitamin B12. It is unlikely this interaction will deplete body stores of vitamin B12 unless there are other factors contributing to deficiency. In a group of children treated with cholestyramine for up to 2.5 years, there was not any change in serum vitamin B12 levels. Routine supplements are not necessary.
H2-receptor antagonists: include cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), and ranitidine (Zantac). Reduced secretion of gastric acid and pepsin produced by H2 blockers can reduce absorption of protein-bound (dietary) vitamin B12, but not of supplemental vitamin B12. Gastric acid is needed to release vitamin B12 from protein for absorption. Clinically significant vitamin B12 deficiency and megaloblastic anemia are unlikely, unless H2 blocker therapy is prolonged (2 years or more), or the person's diet is poor. It is also more likely if the person is rendered achlorhydric(with complete absence of gastric acid secretion), which occurs more frequently with proton pump inhibitors than H2 blockers. Vitamin B12 levels should be monitored in people taking high doses of H2 blockers for prolonged periods.
Metformin (Glucophage): Metformin may reduce serum folic acid and vitamin B12 levels. These changes can lead to hyperhomocysteinemia, adding to the risk of cardiovascular disease in people with diabetes.[citation needed] There are also rare reports of megaloblastic anemia in people who have taken metformin for five years or more. Reduced serum levels of vitamin B12 occur in up to 30% of people taking metformin chronically.[20][21] However, clinically significant deficiency is not likely to develop if dietary intake of vitamin B12 is adequate. Deficiency can be corrected with vitamin B12 supplements even if metformin is continued. The metformin-induced malabsorption of vitamin B12 is reversible by oral calcium supplementation.[22] The general clinical significance of metformin upon B12 levels is as yet unknown.[23]
Neomycin: Absorption of vitamin B12 can be reduced by neomycin, but prolonged use of large doses is needed to induce pernicious anemia. Supplements are not usually needed with normal doses.
Nicotine: Nicotine can reduce serum vitamin B12 levels. The need for vitamin B12 supplementation in smokers has not been adequately studied.
Nitrous oxide: Nitrous oxide inactivates the cobalamin form of vitamin B12 by oxidation. Symptoms of vitamin B12 deficiency, including sensory neuropathy, myelopathy, and encephalopathy, can occur within days or weeks of exposure to nitrous oxide anesthesia in people with subclinical vitamin B12 deficiency. Symptoms are treated with high doses of vitamin B12, but recovery can be slow and incomplete. People with normal vitamin B12 levels have sufficient vitamin B12 stores to make the effects of nitrous oxide insignificant, unless exposure is repeated and prolonged (such as recreational use). Vitamin B12 levels should be checked in people with risk factors for vitamin B12 deficiency prior to using nitrous oxide anesthesia. Chronic nitrous oxide B12 poisoning (usually from use of nitrous oxide as a recreational drug), however, may result in B12 functional deficiency even with normal measured blood levels of B12.[24]
Phenytoin (Dilantin), phenobarbital, primidone (Mysoline): These anticonvulsants have been associated with reduced vitamin B12 absorption, and reduced serum and cerebrospinal fluidlevels in some patients. This may contribute to the megaloblastic anemia, primarily caused by folate deficiency, associated with these drugs. It is also suggested that reduced vitamin B12 levels may contribute to the neuropsychiatric side effects of these drugs. Patients should be encouraged to maintain adequate dietary vitamin B12 intake. Folate and vitamin B12 status should be checked if symptoms of anemia develop.
Proton pump inhibitors (PPIs): The PPIs include omeprazole (Prilosec, Losec), lansoprazole(Prevacid), rabeprazole (Aciphex), pantoprazole (Protonix, Pantoloc), and esomeprazole (Nexium). The reduced secretion of gastric acid and pepsin produced by PPIs can reduce absorption of protein-bound (dietary) vitamin B12, but not supplemental vitamin B12. Gastric acid is needed to release vitamin B12 from protein for absorption. Reduced vitamin B12 levels may be more common with PPIs than with H2-blockers, because they are more likely to produce achlorhydria (complete absence of gastric acid secretion). However, clinically significant vitamin B12 deficiency is unlikely, unless PPI therapy is prolonged (2 years or more) or dietary vitamin intake is low. Vitamin B12 levels should be monitored in people taking high doses of PPIs for prolonged periods.
Zidovudine (AZT, Combivir, Retrovir): Reduced serum vitamin B12 levels may occur when zidovudine therapy is started. This adds to other factors that cause low vitamin B12 levels in people with HIV, and might contribute to the hematological toxicity associated with zidovudine. However, the data suggest vitamin B12 supplements are not helpful for people taking zidovudine.[citation needed]
Folic acid: Folic acid, particularly in large doses, can mask vitamin B12 deficiency by completely correcting hematological abnormalities. In vitamin B12 deficiency, folic acid can produce complete resolution of the characteristic megaloblastic anemia, while allowing potentially irreversible neurological damage (from continued inactivity of methylmalonyl mutase) to progress. Thus, vitamin B12 status should be determined before folic acid is given as monotherapy.
Potassium: Potassium supplements can reduce absorption of vitamin B12 in some people. This effect has been reported with potassium chloride and, to a lesser extent, with potassium citrate. Potassium might contribute to vitamin B12 deficiency in some people with other risk factors, but routine supplements are not necessary.[ |
| Drug Pregnancy Interaction |
no data available |
| Drug Breast feeding Interaction |
no data available |
| Drug Machinery Interaction |
no data available |
| Drug More Information |
Alcohol (ethanol): Excessive alcohol intake lasting longer than two weeks can decrease vitamin B12 absorption from the gastrointestinal tract.[c |
| How to take the
Medicine
|
| Consumption Info |
no data available |
| Drug quanitty |
The dietary reference intake for an adult ranges from 2 to 3 µg per day.[9]
Vitamin B12 is believed to be safe when used orally in amounts that do not exceed the recommended dietary allowance (RDA). There have also been studies that showed no adverse consequences of doses above the RDA.[10] The RDA for vitamin B12 in pregnant women is 2.6 µg per day and 2.8 µg during lactation periods.[citation needed] There is insufficient reliable information available about the safety of consuming greater amounts of vitamin B12 during pregnancy.
The Vegan Society, the Vegetarian Resource Group, and the Physicians Committee for Responsible Medicine, among others, recommend that vegans either consistently eat foods fortified with B12 or take a daily or weekly B12 supplement.[11][12][13] Fortified breakfast cereals are a particularly valuable source of vitamin B12 for vegetarians and vegans. In addition, adults age 51 and older are recommended to consume B12 fortified food or supplements to meet the RDA, because they are a population at an increased risk of deficiency |
| Drug Dose |
Can you take too much? No. Unlike other supplements which you can overdose on, your body doesn’t store excess vitamin B12. But you don’t want to waste it. I usually go with ~1cc every week or so. |
| Excess Drug Consumption |
no data available |
| Forgot Drug Consumption |
contact your doctor |
| Stop Drug Consumption |
do not stop the medicine untill adviced by your doctor |
| Possible Side
Effects
|
| General Information |
no data available |
| Common Drug Side Effects |
Vitamin B12 has extremely low toxicity and even taking it in enormous doses appears not to be harmful to healthy individuals.[17][18]
Hematologic: Peripheral vascular thrombosis has been reported. Treatment of vitamin B12 deficiency can unmask polycythemia vera, which is characterized by an increase in blood volume and the number of red blood cells. The correction of megaloblastic anemia with vitamin B12 can result in fatal hypokalemia and gout in susceptible individuals, and it can obscure folate deficiency in megaloblastic anemia. Caution is warranted.
Leber's disease: Vitamin B12 in the form of cyanocobalamin is contraindicated in early Leber's disease, which is hereditary optic nerve atrophy. Cyanocobalamin can cause severe and swift optic atrophy, but other forms of vitamin B12 are available. However, the sources of this statement are not clear, while an opposing view[19] concludes: "The clinical picture of optic neuropathy associated with vitamin B12 deficiency shows similarity to that of Leber's disease optic neuropathy. Both involve the nerve fibres of the papillomacular bundle. The present case reports suggest that optic neuropathy in patients carrying a primary LHON mtDNA mutation may be precipitated by vitamin B12 deficiency. Therefore, known carriers should take care to have an adequate dietary intake of vitamin B12 and malabsorption syndromes like those occurring in familial pernicious anaemia or after gastric surgery should be excluded." |
| Rare Drug Side Effects |
no data available |
| Very Rare Drug Side Effects |
no data available |
| Drug Side Effects Symptoms |
no data available |
| How to Store the
Medicine
|
| How to Store the Medicine |
Precautions:
Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate the residue under a
fume hood. Ground all equipment containing material. Do not ingest. Do not breathe dust. If ingested, seek medical advice
immediately and show the container or the label. Keep away from incompatibles such as oxidizing agents.
Storage: Keep container tightly closed. Keep container in a cool, well-ventilated area. |
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