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Levant

Syria is a country located in the Middle East on the shore of Mediterranean Sea and bordered, from the north down to the west, by Turkey, Iraq, Jordan, Israel, and Lebanon. It is one of the oldest inhabited regions in the world with archaeological finds dating the first human habitation at c. 700,000 years ago. The Dederiyeh Cave near Aleppo has produced a number. [continue reading ]

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IBUPROFEN 400 MG TABLETS

Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

ADVIL 400MG TABLETS

Transcript

Advil 400mg Tablets 0140_PIL_15 080_v1 PL 0165/0140 PACKAGE LEAFLET: INFORMATION FOR THE USER Advil 400 mg Tablets Contains ibuprofen Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. This medicine is available without prescription, for you to treat a mild illness without a doctor’s help. Nevertheless, you still need to use your medicine carefully to get the best results - Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet, you may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, or if any of the side effects gets serious, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must see a doctor if your symptoms worsen or persist. See section 3. What is in this leaflet: 1. What Advil 400 mg is and what it is used for 2. What you need to know before you take Advil 400 mg 3. How to take Advil 400 mg 4. Possible side effects 5. How to store Advil 400 mg 6. Contents of the pack and other information 1. WHAT ADVIL 400 MG IS AND WHAT IT IS USED FOR Each tablet contains 400 mg of ibuprofen. Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) that work by relieving pain and reducing inflammation, swelling and fever. Advil 400 mg is for the relief of mild to moderate pain including: rheumatic and muscular pain, backache, headache, toothache, dysmenorrhoea, feverishness, symptoms of colds and influenza. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADVIL 400 MG Please read the following information. Do not give to children under 12 years of age, except on the advice of a doctor. Do not take Advil 400 mg if you: • are suffering from or have had two or more separate occurrences of stomach ulcers or bleeding. • have suffered in the past from stomach bleeding or perforation because of treatment with this medicine or any other NSAID. • suffer from other bleeding conditions or blood disease. • are allergic to ibuprofen or any of the other ingredients of this product, aspirin, or any other NSAID painkiller. • suffer from severe liver, kidney or heart failure. • are in the last 3 months of pregnancy. Warnings and Precautions Talk to your pharmacist or your doctor if you : • are asthmatic or suffer from hayfever. • are suffering from liver or kidney problems.

Advil 400mg Tablets 0140_PIL_15 080_v1 PL 0165/0140 • are suffering from autoimmune diseases including Systemic Lupus Erythematosus (SLE), a condition of the immune system affecting connective tissue resulting in joint pain, skin changes and disorders of other organs. • are suffering from or have a history of gastro-intestinal disorders, such as ulcerative colitis or Crohn’s Disease, because medicines such as ibuprofen may make these conditions worse. ? are in the first 6 months of pregnancy. ? are 12-18 years old as there is a risk of renal impairment. Therefore ask a doctor before use if a child or adolescent between 12-18 years of age has not been drinking fluids or has lost fluids due to continuous vomiting or diarrhoea. ? have heart problems including heart failure, angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”). ? have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker. Medicines such as Advil 400 mg Tablets may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. See section 3. Other medicines and Advil 400 mg Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Do not use this medicine if you are taking aspirin/acetylsalicylic acid with a daily dose above 75 mg, or other NSAID painkillers. Talk to you doctor or pharmacist if you are taking: • medicines that are anti-coagulants (i. e thin blood/prevent clotting, e. g. aspirin/acetylsalicylic acid, warfarin, ticlopidine), diuretics (water tablets - increase the amount of urine you produce) ? medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan), or other medicines, as these may affect or be affected by treatment with ibuprofen. • other medicines such as corticosteroids (used in the management of asthma and to treat skin diseases and other conditions), anti-platelet agents (generally used to thin the blood to help prevent stroke or heart problems), cardiac glycosides (used in patients with heart problems), selective serotonin reuptake inhibitors (SSRIs) or lithium (used to treat depression), methotrexate (used in the treatment of some cancers, and to treat psoriasis or rheumatoid arthritis), ciclosporin or tacrolimus (used in patients receiving organ transplants, and to treat some skin disorders), zidovudine (used to treat HIV infection), quinolone antibiotics (a class of antibiotics used to treat some infections), phenytoin (used in the treatment of epilepsy) or antacids (used to treat indigestion). Some other medicines may also affect or be affected by the treatment of Advil 400mg. You should therefore always seek the advice of a doctor or pharmacist before you take Advil 400mg with other medicines. Pregnancy and breastfeeding Ibuprofen belongs to a group of medicines, NSAIDs, which may impair fertility in women. This effect is reversible upon stopping the medicine. It is unlikely that ibuprofen, used occasionally, will affect your chances of becoming pregnant, however tell your doctor before using this medicine if you have problems becoming pregnant or are trying to become pregnant. If you are in the first 6 months of pregnancy talk to your doctor before taking ibuprofen.

Advil 400mg Tablets 0140_PIL_15 080_v1 PL 0165/0140 Do not take ibuprofen during the last 3 months of pregnancy, Ibuprofen appears in breast milk in very low concentrations, but this is unlikely to adversely affect the breast-fed infant. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 3. HOW TO TAKE ADVIL 400 MG This product is intended for short term use only. You should only take the lowest dose for the shortest time necessary to relieve your symptoms. If you are aged between 12 and 18 years and the product is required for more than 3 days or if the symptoms worsen, you should contact your doctor. If you are 18 years or older, you should not take this medicine for longer than 10 days unless your doctor tells you to. If symptoms persist or worsen consult your doctor. The recommended dose for Adults, older people and children and adolescents between 12-18 years of age: 1 tablet up to 3 times a day as required. The recommended interval between doses is approximately 6 to 8 hours, and you must leave at least 4 hours between doses. Do not take more than 3 tablets in any 24 hour period. The tablet should be taken with water. Do not chew. If you take more Advil 400 mg than you should If you take too many tablets, contact your doctor or hospital immediately. Bring the remaining tablets with you to show the doctor. If you forget to take Advil 400 mg Do not take a double dose to make up for a forgotten dose If you have questions regarding the use of Advil 400 mg, ask your doctor or pharmacist

Advil 400mg Tablets 0140_PIL_15 080_v1 PL 0165/0140 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects are very rare (less than 1 in 10,000 people) but if you experience any of these STOP taking this medicine immediately and contact your doctor or pharmacist: • Stomach ulceration or perforation. Symptoms could include severe abdominal pain, vomiting blood (or liquid with what looks like coffee grounds), blood in the faeces (stools/motions) or passing black tarry stools. • Inflammation of the brain lining (meningitis). Symptoms could include stiff neck, headache, feeling or being sick, fever, or feeling disorientated. • Severe allergic reactions (could be life-threatening). Symptoms may include sudden signs of allergy such as rash, itching, or hives on the skin, fainting, low blood pressure, faster heart rate, swelling of the face, tongue and throat, shortness of breath, wheezing or trouble breathing. • Asthma / worsening of asthma and other breathing difficulties. • Severe conditions of the skin that may affect the mouth and other parts of the body. This may progress to a severe skin reaction which starts with painful red areas, then large blisters, and ends up with peeling of layers of skin around the mouth, nose, eyes or genitals. This may be accompanied by fever and chills, aching muscles and generally feeling unwell. • Liver problems. Symptoms could include yellowing of the skin or the whites of the eyes. Medicines such as ibuprofen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Other possible side effects If any of the following side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. Less than 1 in 100 people may experience the following uncommon side effects: • Allergic reactions such as hives, skin rashes and itching (or Systemic Lupus Erythematosus SLE). • Abdominal pain, indigestion, heartburn and feeling sick. • Headache or dizziness. Less than 1 in 1,000 people may experience the following rare side effects: • Diarrhoea, wind, constipation or being sick. Less than 1 in 10,000 people may experience the following very rare side effects: • Reduction in blood cells, which can make the skin pale or yellow, cause fever, sore throat, mild mouth ulcers, flu-like symptoms, exhaustion or weakness, easy bruising, or bleeding from the skin or nose. • High blood pressure, heart failure or chest pain. • Nervousness, visual disturbance, ringing in the ears and dizziness. • Kidney problems. Symptoms could include swelling of the ankles. • Severe skin reactions. Symptoms could include blistering. • Blood in urine, or foamy appearance of urine. Other very rare side effects with unknown frequency: • Worsening of symptoms of colitis and Crohn’s disease. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Advil 400mg Tablets 0140_PIL_15 080_v1 PL 0165/0140

You can also report side effects directly via the Yellow Card Scheme at www. mhra. gov. uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE YOUR MEDICINE • • •

Do not use this medicine after the expiry date stated on the side of the carton. The expiry date refers to the last day of the month. Do not store your medicine above 30°C. Keep this medicine out of the sight and reach of children.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment 6. CONTENTS OF THE PACK AND OTHER INFORMATION What Advil 400mg contains The active substance is ibuprofen. Each tablet contains 400 mg of ibuprofen. The other ingredients are maize starch, pregelatinised starch, croscarmellose sodium, colloidal silicon dioxide, stearic acid, sodium lauryl sulfate, hydroxypropyl methylcellulose, macrogol 6000, titanium dioxide (E171), iron oxide (E172), talc, black ink (black iron oxide (E172), shellac, propylene glycol and ammonium hydroxide (E527)). What Advil 400mg looks like and contents of the pack Advil 400 mg Tablets are brown, film-coated capsule-shaped tablets, printed on one side in black. ink. The blister packs contain 10, 12, 20, 24, 30, 36, 40, 48, 50, or 60 tablets. The bottles contain 20 or 50 tablets. (Not all pack sizes may be marketed.) Who your medicine is made by The Marketing Authorisation holder is: Pfizer Consumer Healthcare Ltd, Sandwich, Kent, CT13 9NJ, UK. The manufacturer is: Pfizer Consumer Manufacturing Italy S. r.l. Via Nettunense, 90 – 04011 Aprilia (LT), Italy. This medicinal product is authorised in the Member States of the EEA under the following names: Ireland – Seclodin 400 mg Tablets Netherlands – Advil Oval-Tabs 400, filmomhulde tabletten 400 mg United Kingdom – Advil 400 mg Tablets This leaflet was last revised in: September 2015. PL 0165/0140

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

What are the active ingredients in Advil ® PM caplets?

Each Advil ® PM caplet contains 200 mg of ibuprofen and 38 mg of diphenhydramine citrate, a gentle sleep aid. The ibuprofen relieves pain, while the diphenhydramine helps you get a full night’s sleep. The combination of these ingredients not only reduces your pain, it shortens the time it takes to fall asleep and increases the duration of your sleep. The result: a better night's sleep.

What is the recommended dosage for Advil ® PM caplets?

The recommended dose of Advil ® PM caplets is two caplets at bedtime, for adults and children 12 years and older. The two caplet dose contains a combined total of 400 mg of ibuprofen and 76 mg of diphenhydramine citrate. You should not take more than 2 capsules in 24 hours. Stop use and ask a doctor if: pain gets worse or lasts more than 10 days or if sleeplessness persists continuously for more than 2 weeks.

Can I take Advil ® PM caplets with alcohol?

Avoid drinking alcohol. Advil ® PM contains diphenhydramine, which may cause drowsiness - alcohol may intensify this side effect temporarily.

Is Advil ® PM addictive?

Like any drug you become dependent on, Advil ® PM can cause addiction problems. While the drug itself is not considered to be "addictive", the associations people can form with the drug and its results can create a dependency.

Single 400mg Dose OTC Ibuprofen Superior to 200mg for Pain Relief

LAS VEGAS, NV — A meta-analysis presented at PAINWeek 2012 of two standard single over-the-counter (OTC) doses of immediate-release ibuprofen showed that 400 mg provided significantly better overall pain relief compared with 200 mg over a 6-hour period. Both doses of ibuprofen provided significantly better overall pain relief compared with placebo over the 6-hour period.

Drs. Shyamalie Jayawardena and Paul Butkerait, from Pfizer Consumer Healthcare, Madison, NJ, reported the results of their analysis at PAINWeek 2012. The researchers designed the meta-analysis to investigate the analgesic dose-response relationship between 200 mg and 400 mg doses of immediate-release ibuprofen in oral surgery studies. The researchers noted that current OTC dosing instructions for ibuprofen state that adults and children > 12 years may take 1 tablet (200 mg) every 4–6 hours while symptoms persist or for up to 10 days. If pain does not respond to 1 tablet, 2 tablets (40 0mg) may be used (maximum 6 tablets/day).

To compare the efficacy of the two OTC doses, the researchers used Total Pain Relief scores over 6 hours (TOTPAR6), the maximum labeled dosing interval for OTC ibuprofen. Pain relief was measured using a categorical scale from 0 (no pain relief) to 4 (complete pain relief) at prespecified time points. A separate analysis was conducted for each comparison (400 mg vs. placebo, 200 mg vs. placebo, and 400 mg vs. 200 mg), using only those studies that concurrently evaluated the doses being compared.

The search identified 931 clinical studies, and 38 unique studies were included in the meta-analysis. Of these, 13 evaluated 200 mg ibuprofen, 32 evaluated 400 mg ibuprofen, and seven evaluated both 200- and 400-mg doses of ibuprofen. The pooled estimate for the treatment difference for the 400mg (n=2,890) vs. placebo (n=1,486) comparison was 9.58 (95% CI; 8.80–10.36). The pooled estimate for the treatment difference for the 200mg (n=1,036) vs. placebo (n=653) comparison was 6.89 (95% CI; 5.42–8.35). Both the 400mg and 200mg vs. placebo comparisons were statistically significant ( P <0.001). For the 400mg (n=716) vs. 200mg (n=714) comparison, the pooled estimate for the treatment difference was 1.39 (95% CI; 0.41–2.37). This comparison was also statistically significant ( P= 0.013). Both the 400-mg and 200-mg doses of ibuprofen were well tolerated across all studies and the incidence of adverse events was similar for both doses.

In conclusion, the study investigators' results were confirmed by data from the seven studies that simultaneously evaluated both doses of ibuprofen. The results of this meta-analysis are consistent with other reports in the literature on the efficacy and safety of OTC ibuprofen for pain relief following oral surgery.



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Carbamazepine Side Effects

Commonly reported side effects of carbamazepine include: dizziness, drowsiness, nausea, ataxia, and vomiting. Other side effects include: speech disturbance, pruritus, xerostomia, and amblyopia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to carbamazepine: oral capsule extended release, oral suspension, oral tablet, oral tablet chewable, oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by carbamazepine. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking carbamazepine:

More common:

Blurred vision or double vision

continuous back-and-forth eye movements

Less common:

Actions that are out of control

behavioral changes (especially in children)

confusion, agitation, or hostility (especially in the elderly)

diarrhea (severe)

discouragement

drooling

fear

feeling of unreality

feeling sad or empty

headache (continuing)

increase in seizures

irritability

lack of appetite

loss of balance control

loss of interest or pleasure

muscle trembling, jerking, or stiffness

nausea and vomiting (severe)

other problems with muscle control or coordination

sense of detachment from self or body

shakiness and unsteady walk

shuffling walk

stiffness of the limb

sudden, wide mood swings

talking, feeling, and acting with excitement

thoughts or attempts of killing oneself

tiredness

trouble concentrating

trouble sleeping

twisting movements of the body

uncontrolled movements, especially of the face, neck, and back

unusual drowsiness

Rare

Black, tarry stools

blood in the urine or stools

bone or joint pain

chest pain

cough or hoarseness

darkening of the urine

difficulty with speaking or slurred speech

fainting

frequent urination

irregular, pounding, or unusually slow heartbeat

lower back or side pain

mental depression with restlessness and nervousness or other mood or mental changes

muscle or stomach cramps

nosebleeds or other unusual bleeding or bruising

numbness, tingling, pain, or weakness in the hands and feet

pain, tenderness, swelling, or bluish color in the leg or foot

painful or difficult urination

pale stools

pinpoint red spots on the skin

rapid weight gain

rigidity

ringing, buzzing, or other unexplained sounds in the ears

skin rash, hives, or itching

sore throat, chills, and fever

sores, ulcers, or white spots on the lips or in the mouth

swelling of the face, hands, feet, or lower legs

swollen or painful glands

sudden decrease in the amount of urine

tightness in the chest

trembling

troubled breathing

uncontrolled body movements

unusual tiredness or weakness

visual hallucinations (seeing things that are not there)

yellow eyes or skin

Minor Side Effects

Some of the side effects that can occur with carbamazepine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

Dizziness (mild)

drowsiness (mild)

lightheadedness

nausea or vomiting (mild)

Less common or rare:

Accidental injury

aching joints or muscles

acid or sour stomach

back pain

belching

constipation

diarrhea

dryness of the mouth

headache

heartburn

increased sensitivity of the skin to sunlight (skin rash, itching, redness or other discoloration of the skin, or severe sunburn)

increased sweating

indigestion

irritation or soreness of the tongue or mouth

itching skin

lack or loss of strength

loss of hair

loss of memory

problems with memory

sexual problems in males

sleepiness

stomach pain, upset, or discomfort

For Healthcare Professionals

Applies to carbamazepine: compounding powder, oral capsule extended release, oral suspension, oral tablet, oral tablet chewable, oral tablet extended release

Gastrointestinal

Very common (10% or more): Nausea (29%), vomiting (18%), constipation (10%) Very rare (less than 0.01%): Colitis, glossitis, stomatitis, pancreatitis Frequency not reported: Dryness of the mouth, with suppositories occasional rectal irritation may occur, diarrhea, oral ulceration Postmarketing reports: Gastric distress, abdominal pain, anorexia [Ref ]

A single case of chemical pancreatitis has been reported in association with carbamazepine intoxication. [Ref ]

Endocrine

Carbamazepine increases the rate of T4 and T3 metabolism and may lead to hypothyroidism in patients with hypothyroidism who are being treated with T4. Carbamazepine may also cause a 20% to 40% decrease in serum total and free T4 concentrations and a smaller decrease in serum total and free T3 concentrations in patients who have no thyroid disease.

Chronic administration of carbamazepine may increase total cholesterol and HDL cholesterol levels. Carbamazepine may also transiently increase serum triglyceride and LDL cholesterol levels. One study has suggested that demeclocycline may be useful in prophylaxis of carbamazepine-induced hyponatremia. [Ref ]

Very rare (less than 0.01%): Increase in prolactin (with or without symptoms such as gynecomastia or galactorrhea), impaired male fertility and/or abnormal spermatogenesis, abnormal thyroid function tests (e. g. decreased L-thyroxine [FT4, T4, T3] and increased TSH) Frequency not reported: Hyponatremia, pancreatitis, lower serum testosterone, lower free androgen indexes, increased cerebrospinal fluid thyrotropin-releasing hormone levels [Ref ]

Hematologic

Very common (10% or more): Leucopenia Common (1% to 10%): Eosinophilia, thrombocytopenia, neutropenia Rare (0.01% to 0.1%): Leukocytosis, lymphadenopathy, folic acid deficiency Very rare (less than 0.01%): Agranulocytosis, aplastic anemia, pure red cell aplasia, megaloblastic anemia, acute intermittent porphyria, reticulocytosis, hemolytic anemia Frequency not reported: Aplastic anemia, pancytopenia, bone marrow depression, leukopenia, thrombophlebitis, thromboembolism, adenopathy [Ref ]

Thrombocytopenia is the most common hematologic effect of carbamazepine and may be either mild and transient or severe. Significant decreases in white blood cell counts may occur although the values may still be within the normal range. Often counts will return to baseline during continued therapy, and therefore, discontinuation of carbamazepine may not be necessary. Dose reductions may also result in normalization of white blood cell counts. Aplastic anemia has been reported (although many of the reported cases had confounding exposures to other medications). The manufacturer reports an incidence of 2 per 1,000,000 patients for aplastic anemia and 6 per 1,000,000 patients for agranulocytosis. Cases of reticulocytosis have been reported rarely in association with carbamazepine therapy as well. In addition, cases of hemolytic anemia and erythroid arrest have been reported.

Both humoral and nonimmune mechanisms have been implicated in the etiology of carbamazepine-induced bone marrow suppression. [Ref ]

Cardiovascular

Rare (0.01% to 0.1%): Disturbances of cardiac conduction Very rare (less than 0.01%): Bradycardia, arrhythmias, AV-block with syncope, collapse, congestive heart failure, hypertension or hypotension, aggravation of coronary artery disease, thrombophlebitis, thromboembolism [Ref ]

Most of the cases of cardiovascular effects reported have occurred in patients receiving carbamazepine for trigeminal neuralgia. The reported effects included congestive heart failure, edema, hypotension, syncope and arrhythmias. In general, the doses were titrated quickly because of severe pain. Many of the doses were higher than those used to treat epilepsy. Many of the reported cardiovascular effects resolved after discontinuation of carbamazepine.

Increased sympathetic activity in the setting of seizure-induced hypoxia could predispose a patient to sudden unexpected death in epilepsy (SUDEP). [Ref ]

Nervous system

Very common (10% or more): Dizziness (44%), somnolence (32%), ataxia (15%) Common (1% to 10%): Headache, tremor, vertigo Uncommon (0.1% to 1%): Abnormal involuntary movements (tremor, asterixis, dystonia, tics) Rare (less than 0.1%): Choreoathetotic disorders, orofacial dyskinesia, oculomotor disturbances, speech disorders (e. g. dysarthria or slurred speech), peripheral neuritis, paresthesia, paretic symptoms, neuroleptic malignant syndrome Frequency not reported: Drowsiness, fatigue, fever and chills [Ref ]

Rigidity and oculogyric crises have been reported. Euphoria has also been reported and has led to abuse of carbamazepine in some patients. Impairment of psychomotor function has been noted in association with use of the liquid suspension of carbamazepine. Additionally, impaired cognition, exacerbations of focal seizures and asterixis have been reported in association with carbamazepine treatment. One case of a lingual-facial-buccal extrapyramidal reaction has also been described.

One study has suggested that gradual withdrawal of carbamazepine over ten days results in significantly fewer generalized tonic-clonic seizures compared to rapid withdrawal over four days.

One study has suggested that the epoxide metabolite of carbamazepine may be responsible for the occasional occurrence of seizure exacerbations in patients receiving carbamazepine. [Ref ]

Hypersensitivity

Rare (0.01% to 0.1%): A delayed multi-organ hypersensitivity disorder (of serum sickness type) with fever, skin rashes, vasculitis, lymphadenopathy, disorders mimicking lymphoma, arthralgia, leucopenia, eosinophilia, hepato-splenomegaly and abnormal liver function tests, occurring in various combinations, other organs may also be affected (e. g. lungs, kidneys, pancreas, myocardium, colon) Very rare (less than 0.01%): Aseptic meningitis (with myoclonus and peripheral eosinophilia), anaphylactic reaction, angioedema Frequency not reported: Multiorgan hypersensitivity reactions occurring days, weeks, or months after initiating treatment [Ref ]

Rash and pruritus often resolve after discontinuation of carbamazepine therapy. Both cases of lupus-like syndrome resolved after discontinuation of carbamazepine. Stevens-Johnson syndrome, erythema multiforme, and a mononucleosis-like syndrome have also been reported. [Ref ]

Hepatic

Very common (10% or more): Elevated gamma-GT (due to hepatic enzyme induction) usually not clinically relevant Common (1% to 10%): Elevated alkaline phosphatase Uncommon (0.1% to 1%): Elevated transaminases Rare (0.01% to 0.1%): Cholestatic and hepatocellular jaundice, hepatitis of cholestatic, parenchymal (hepatocellular), or mixed type Very rare (less than 0.01%): Granulomatous hepatitis, hepatic failure Frequency not reported: Liver function test abnormalities, variegate porphyria, porphyria cutanea tarda [Ref ]

Alterations in liver function tests may progress to hepatotoxicity including cholangitis, granuloma formation, fever and hepatocellular necrosis. Discontinuation of carbamazepine often results in improvement in laboratory abnormalities and liver injury. [Ref ]

Renal

Very rare (less than 0.01%): Interstitial nephritis, renal failure, renal dysfunction (including albuminuria, hematuria, oliguria, and elevated BUN/azotemia) [Ref ]

Respiratory

Very rare (less than 0.01%): Pulmonary hypersensitivity (characterized by fever, dyspnea, pneumonitis or pneumonia), pulmonary embolism [Ref ]

Dermatologic

Very common (10% or more): Allergic skin reactions, urticaria Common (1% to 10%): Pruritus, rash, paresthesia Uncommon (0.1% to 1%): Exfoliative dermatitis, erythroderma Rare (0.01% to 0.1%): Systemic lupus erythematosus-like syndrome Very rare (less than 0.01%): Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), photosensitivity, erythema multiforme, erythema nodosum, alterations in skin pigmentation, purpura, acne, sweating, alopecia, hirsutism, unusual bruising, pruritic and erythematous rashes, diaphoresis, onychomycosis, dermatitis Frequency not reported: Psoriasiform eruption [Ref ]

Dangerous, sometimes fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy are significantly more common in patients with the human leukocyte antigen (HLA) allele, HLA-B 1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians. Patients with ancestry from areas in which HLA-B 1502 is present should be screened for the HLA-B 1502 allele before starting treatment with carbamazepine. If these individuals test positive, carbamazepine should not be started unless the expected benefit clearly outweighs the increased risk of serious skin reactions. Patients who have been taking carbamazepine for more than a few months without developing skin reactions are at low risk of these events ever developing from carbamazepine. This is true for patients of any ethnicity or genotype, including patients who test positive for HLA-B 1502. [Ref ]

Ocular

Common (1% to 10%): Diplopia, accommodation disorders (blurred vision) Very rare (less than 0.01%): Lens opacities, conjunctivitis Postmarketing reports: Diplopia, oculomotor disturbances, nystagmus, photosensitivity, visual hallucinations, scattered punctate cortical lens opacities, overall impairment of the chromatic and achromatic systems, increased intraocular pressure [Ref ]

Oncologic

Frequency not reported: Disorders mimicking lymphoma [Ref ]

Immunologic

Frequency not reported: Antibody deficiency Postmarketing reports: Aseptic meningitis (with myoclonus and peripheral eosinophilia) [Ref ]

Psychiatric

Common (1% to 10%): Abnormal thinking Rare (0.01% to 0.1%): Hallucinations (visual or acoustic), depression, loss of appetite, restlessness, aggressive behavior, agitation, confusion, talkativeness Very rare (less than 0.01%): Activation of psychosis, rebound mania following discontinuation of therapy [Ref ]

Genitourinary

Very rare (less than 0.01%): Sexual disturbances/impotence, abnormal spermatogenesis (with decreased sperm count and/or motility) Frequency not reported: Urinary frequency, acute urinary retention, oliguria with elevated blood pressure, azotemia, albuminuria, glycosuria, elevated BUN, microscopic deposits in the urine [Ref ]

Metabolic

Common (1% to 10%): Hyponatremia, fluid retention, edema, weight gain, reduced plasma osmolarity due to an antidiuretic hormone (ADH)-like effect (leading in rare cases to water intoxication accompanied by lethargy) Very rare (less than 0.01%): Disturbances of bone metabolism (decrease in plasma calcium and 25-OH-cholecalciferol) leading to osteomalacia, elevated cholesterol (including HDL cholesterol), elevated triglycerides [Ref ]

Musculoskeletal

Rare (0.01% to 0.1%): Muscle weakness Very rare (less than 0.01%): Arthralgia Postmarketing reports: Leg cramps [Ref ]

Other

Very rare (less than 0.01%): Taste disturbances, tinnitus, hyperacusis, hypoacusis, changes in pitch perception [Ref ]

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Not all side effects for carbamazepine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here .



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