L.M.X.4

Ingredient matches for L.M.X.4

Lidocaine

Lidocaine is reported as an ingredient of L.M.X.4 in the following countries:

• United States

International Drug Name Search

Bronchotussine

Bronchotussine may be available in the countries listed below.

Ingredient matches for Bronchotussine

Bromhexine

Bromhexine hydrochloride (a derivative of Bromhexine) is reported as an ingredient of Bronchotussine in the following countries:

• Greece


• Malta

International Drug Name Search

Mirena

Generic Name: levonorgestrel (Intrauterine route)

lee-voe-nor-JES-trel

Commonly used brand name(s)

In the U.S.

• Mirena

Available Dosage Forms:

• Insert, Extended Release

Therapeutic Class: Contraceptive, Local

Pharmacologic Class: Progestin

Uses For Mirena

Levonorgestrel-releasing intrauterine system is a device that contains the female hormone, levonorgestrel. It is placed in the uterus (womb) where it slowly releases the hormone to prevent pregnancy for up to five years. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

Levonorgestrel-releasing intrauterine system is also used to treat heavy menstrual bleeding in women. It works best in women who have had at least one child.

This medicine is available only with your doctor's prescription.

Before Using Mirena

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of levonorgestrel in teenage females. This medicine may be used for birth control in teenage females but is not recommended before the start of menstruation.

Geriatric

Appropriate studies on the relationship of age to the effects of levonorgestrel have not been performed in the geriatric population. This medicine is not recommended for use in elderly women.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Isotretinoin


• Theophylline


• Tizanidine


• Tranexamic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acitretin


• Alprazolam


• Amoxicillin


• Ampicillin


• Amprenavir


• Aprepitant


• Atazanavir


• Bacampicillin


• Betamethasone


• Bexarotene


• Bosentan


• Carbamazepine


• Colesevelam


• Cyclosporine


• Darunavir


• Delavirdine


• Doxycycline


• Efavirenz


• Etravirine


• Fosamprenavir


• Fosaprepitant


• Fosphenytoin


• Griseofulvin


• Lamotrigine


• Licorice


• Minocycline


• Modafinil


• Mycophenolate Mofetil


• Mycophenolic Acid


• Nelfinavir


• Nevirapine


• Oxcarbazepine


• Oxytetracycline


• Phenobarbital


• Phenytoin


• Pioglitazone


• Prednisolone


• Primidone


• Rifabutin


• Rifampin


• Rifapentine


• Ritonavir


• Rosuvastatin


• Rufinamide


• Selegiline


• St John's Wort


• Tacrine


• Telaprevir


• Tetracycline


• Topiramate


• Troglitazone


• Troleandomycin


• Voriconazole


• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or


• Abnormally-shaped uterus or uterine fibroids or


• Breast cancer, known or suspected, or a history of or


• Cancer of the uterus or cervix, known or suspected or


• Infection (e.g., pneumonia, HIV/AIDS) or


• Liver disease, including tumors or cancer or


• Pelvic infection (active or untreated), history of or


• Pelvic inflammatory disease (a serious pelvic infection), or history of—Should not be used in patients with these conditions.

• Bleeding problems or


• Blood clots or


• Diabetes or


• Heart attack, history of or


• Heart disease or other heart problems (e.g., congenital heart disease, heart valve problems) or


• Hypertension (high blood pressure), severe or


• Migraine headaches, severe or


• Stroke, history of—Use with caution. May make these conditions worse.

Proper Use of Mirena

Your doctor will give you this medicine in a hospital or clinic. The intrauterine device (IUD) is inserted into your uterus.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Your doctor may want to do tests to make sure you do not have an infection before putting in an IUD. The IUD is usually inserted during your monthly period or immediately after a miscarriage or an abortion in the first trimester of your pregnancy. Putting an IUD in during a monthly period also helps to make sure that you are not pregnant. You will also need to see your doctor within four to twelve weeks of having your IUD placed and then once a year.

Levonorgestrel IUD has a string or "tail" which is made of plastic thread. About one or two inches of this string hangs into your vagina. You cannot see this string, and it will not cause problems when you have sex. Check your IUD string every few days during the first few months that you have your IUD. After that, check the string after each monthly period. You may not be protected against pregnancy if you cannot feel the string or if you feel plastic. Do the following to check the placement of your IUD:

• Wash your hands with soap and warm water. Dry them with a clean towel.


• Bend your knees and squat low to the ground.


• Gently put your index (pointing) finger high inside your vagina. The cervix is at the top of the vagina and feels like the tip of your nose. Find the IUD string coming from your cervix. Never pull on the string. You should not be able to feel the firm plastic of the IUD itself.


• Wash your hands after you are finished checking your IUD.

You will need to have your levonorgestrel-releasing IUD replaced every five years, or sooner if it comes out of your uterus.

Precautions While Using Mirena

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits will usually be every 4 to 12 weeks after insertion, but some doctors require them more often.

Call your doctor right away if you think you have become pregnant while you are using this medicine. You may have a higher risk of an ectopic pregnancy if you get pregnant while your IUD is in place. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.

An IUD can slip partly or all of the way out of your uterus without you knowing it. If this happens, you will have no protection against getting pregnant or you may have an increased risk for serious problems. This is more likely during the first year that you have your IUD, but can happen at any time. Regularly checking the string of your IUD can tell you if your IUD is still in place.

You may have some blood spotting and cramping during the first few weeks after the IUD has been inserted. These symptoms should go away within a few months. Rarely, the IUD may make a hole in the wall of your uterus when it is inserted. If this happens, check with your doctor right away.

An IUD increases your risk of a serious infection of the female organs called pelvic inflammatory disease (PID). PID can be serious, even life threatening. This infection could cause scarring of the female organs, which may make it hard for you to become pregnant in the future, and can increase your risk of ectopic pregnancy.

Call your doctor right away if you have flu-like symptoms, fever, chills, cramps, pain, bleeding, or fluid leaking from your vagina. These may be signs that you have an infection.

This device will not protect you from getting HIV/AIDS, herpes, or other sexually transmitted diseases. Tell your doctor if you or your partner begin to have sexual intercourse with other people, or you or your partner tests positive for a sexually transmitted disease. If this is a concern for you, talk with your doctor.

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Mirena Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Abdominal or pelvic pain


• absent, missed, or irregular menstrual periods


• longer or heavier menstrual periods


• mild bloating


• stopping of menstrual bleeding


• unusually heavy or unexpected menstrual bleeding


• uterine bleeding between menstrual periods


• vaginal bleeding or spotting

Less common

• Blurred vision


• cramps


• dizziness


• headache


• heavy bleeding


• itching of the vagina or genital area


• itching of the vagina or genitals


• nervousness


• pain


• pain during sexual intercourse


• painful sexual intercourse


• pale skin


• pounding in the ears


• slow or fast heartbeat


• swelling


• thick, white vaginal discharge with mild or no odor


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• white or brownish vaginal discharge

Rare

• Chills


• confusion


• dizziness, lightheadedness, or fainting


• fast heartbeat


• fast, weak pulse


• fever


• pale, cold, clammy skin


• rapid, shallow breathing


• sudden increase in stomach or shoulder pain


• sweating


• unusual or large amount of vaginal bleeding

Incidence not known

• Clear or bloody discharge from nipple


• dimpling of breast skin


• dull or aching abdominal or stomach pain


• foul-smelling vaginal discharge


• increased urge to urinate


• inverted nipple


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lump in the breast or under the arm


• pain on urination


• persistent crusting or scaling of the nipple


• redness or swelling of the breast


• severe abdominal or stomach pain or cramping


• sharp pain on insertion


• shivering fever


• sore on the skin of the breast that does not heal


• unexpected, heavy vaginal bleeding

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Blemishes on the skin


• depression


• pimples

Less common

• Back pain


• breast tenderness or pain


• decreased interest in sexual intercourse


• full or bloated feeling


• hair loss


• hives or welts


• increased hair growth, especially on the face


• increased weight


• itching


• loss in sexual ability, desire, drive, or performance


• nausea


• nervousness


• pressure in the stomach


• rash


• redness of the skin


• skin rash, encrusted, scaly, and oozing


• swelling of the abdominal or stomach area


• thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Mirena side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Mirena resources

• Mirena Side Effects (in more detail)
• Mirena Use in Pregnancy & Breastfeeding
• Mirena Drug Interactions
• Mirena Support Group
• 437 Reviews for Mirena - Add your own review/rating

• Mirena Prescribing Information (FDA)


• Mirena Consumer Overview


• Mirena IUD MedFacts Consumer Leaflet (Wolters Kluwer)


• Levonorgestrel MedFacts Consumer Leaflet (Wolters Kluwer)


• Levonorgestrel Professional Patient Advice (Wolters Kluwer)


• Next Choice Prescribing Information (FDA)


• Plan B Prescribing Information (FDA)


• Plan B Consumer Overview


• Plan B One-Step Consumer Overview


• Plan B One-Step MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Mirena with other medications

• Abnormal Uterine Bleeding
• Birth Control

Vincristine-Mayne

Vincristine-Mayne may be available in the countries listed below.

Ingredient matches for Vincristine-Mayne

Vincristine

Vincristine sulfate (a derivative of Vincristine) is reported as an ingredient of Vincristine-Mayne in the following countries:

• Denmark


• France


• Iceland


• Luxembourg


• Norway

International Drug Name Search

Nurofen 200mg Liquicaps

1. Name Of The Medicinal Product

Nurofen 200mg Liquicaps

2. Qualitative And Quantitative Composition

Each capsule, soft contains Ibuprofen 200mg

Excipients:

Potassium hydroxide

Sorbitol

For a full list of excipients see 6.1.

3. Pharmaceutical Form

Capsule, soft

A clear red oval soft gelatin capsule printed with an identifying logo in white.

4. Clinical Particulars

4.1 Therapeutic Indications

Adults and children over 12 years:

Nurofen 200mg Liquicaps are indicated for the symptomatic relief of rheumatic or muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, colds and influenza symptoms

4.2 Posology And Method Of Administration

For oral administration and short-term use only.

Adults, the elderly and children over 12 years:

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.

The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.

Take one or two capsules, up to three times a day as required.

Leave at least 4 hours between doses.

Do not take more than 6 capsules in any 24 hour period.

4.3 Contraindications

Patients with a known hypersensitivity to ibuprofen or any other constituent of the medicinal product.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).

Patients with a history of, or existing gastrointestinal ulceration/perforation or bleeding, including that associated with NSAIDs. (See Section 4.4)

Patients with severe hepatic failure, severe renal failure or severe heart failure. See also Section 4.4

Use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors – increased risk of adverse reactions (see section 4.5)”

During the last trimester of pregnancy as there is a risk of premature closure of the fetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see Section 4.6).

4.4 Special Warnings And Precautions For Use

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below).

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Respiratory:

Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.

Other NSAIDs:

The use of ibuprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5)

SLE and mixed connective tissue disease:

Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8).

Renal:

Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8)

Hepatic:

Hepatic dysfunction (see Sections 4.3 and 4.8)

Cardiovascular and cerebrovascular effects:

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g.

Impaired female fertility:

There is some evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.

Gastrointestinal:

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).

GI bleeding, ulceration or perforation, which can be fatal has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complaicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

Dermatological:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

The label will include:

Read the enclosed leaflet before taking this product

Do not take if you:

• have (or have had two or more episodes of ) a stomach ulcer, perforation or bleeding

• are allergic to ibuprofen, to any of the ingredients, or to aspirin or other painkillers

• are taking other NSAID pain killers or aspirin with a daily dose above 75mg

Speak to a pharmacist or your doctor before taking if you:

• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems

• Are a smoker

• Are pregnant

This medicine contains 14mg of potassium per dose. To be taken into consideration by patients on a controlled potassium diet.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Contains 50.5mg of sorbitol per dose, a source of 12.6mg of fructose per dose.

If symptoms persist or worsen, or if new symptoms occur, consult your doctor or pharmacist.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Ibuprofen (like other NSAIDs) should be avoided in combination with:

• Aspirin: unless low-dose aspirin (not above 75mg daily) has been advised by a doctor as this may increase the risk of adverse reactions (see Section 4.4).

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

• Other NSAIDs including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.4)

Ibuprofen should be used with caution in combination with:

• Corticosteroids: as these may increase the risk of gastrointestinal ulceration or bleeding (see Section 4.4)

• Antihypertensives and diuretics: since NSAIDs may diminish the effects of these drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

• Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (See section 4.4).

• Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).

• Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

• Lithium: There is evidence for potential increase in plasma levels of lithium.

• Methotrexate: There is evidence for the potential increase in plasma levels of methotrexate.

• Ciclosporin: Increased risk of nephrotoxicity.

• Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

• Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

• Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

• Quinolone antibiotics:Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

4.6 Pregnancy And Lactation

Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Nurofen 200mg Liquicaps should, if possible, be avoided during the first 6 months of pregnancy.

During the 3^rd trimester, ibuprofen is contraindicated as there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child. (See section 4.3 Contraindications).

In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely.

See section 4.4 regarding female fertility.

4.7 Effects On Ability To Drive And Use Machines

None expected at recommended dose and duration of therapy.

4.8 Undesirable Effects

Hypersensitivity reactions have been reported and these may consist of

a. non-specific allergic reactions and anaphylaxis

b. respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm, dyspnoea

c. various skin reactions e.g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme)

The list of the following adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

Gastrointestinal Disorders	Uncommon: Rare: Very rare:	Abdominal pain, dyspepsia and nausea. Diarrhoea, flatulence, constipation and vomiting Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis gastritis. Exacerbation of ulcerative colitis and Crohn's disease (See section 4.4) (see section 4.4)
Nervous System	Uncommon: Very rare	Headache Aseptic meningitis – single cases have been reported very rarely
Kidney	Very rare:	Decrease of urea excretion and oedema can occur. Also, acute renal failure. Papillary necrosis, especially in long-term use, and increased serum urea concentrations have been reported.
Liver	Very rare:	Liver disorders, especially in long-term treatment.
Blood	Very rare:	Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
Skin	Uncommon: Very rare:	Various skin rashes Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis can occur.
Immune System	Very rare:	In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed (see section 4.4)
Hypersensitivity Reactions	Uncommon: Very rare:	Hypersensitivity reactions with urticaria and pruritus. Severe hypersensitivity reactions. Symptoms could be: facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock). Exacerbation of asthma and bronchospasm.

Cardiovascular and Cerebrovascular:

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

4.9 Overdose

In children ingestion of more than 400mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.

Symptoms – Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management –

Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code: M01A E01 Propionic acid derivative.

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans, ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

Clinical evidence demonstrates that when 400mg of ibuprofen is taken the pain relieving effects can last for up to 8 hours.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release aspirin dosing (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no relevant effect is considered to be likely for occasional ibuprofen use.

5.2 Pharmacokinetic Properties

Ibuprofen is well absorbed from the gastrointestinal tract. Ibuprofen is extensively bound to plasma proteins.

Nurofen 200mg Liquicaps consist of ibuprofen 200mg dissolved in a hydrophilic solvent inside a gelatin shell. On ingestion, the gelatin shell disintegrates in the gastric juice releasing the solubilised ibuprofen immediately for absorption. The median peak plasma concentration is achieved approximately 30 minutes after administration.

The median peak plasma concentration for Nurofen tablets is achieved approximately 1-2 hours after administration.

Ibuprofen is metabolised in the liver to two major metabolites with primary excretion via the kidneys, either as such or as major conjugates, together with a negligible amount of unchanged ibuprofen. Excretion by the kidney is both rapid and complete.

Elimination half-life is approximately 2 hours.

No significant differences in pharmacokinetic profile are observed in the elderly.

5.3 Preclinical Safety Data

No relevant information, additional to that contained elsewhere in the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Macrogol 600

Potassium hydroxide 50% solution (E525)

Gelatin

Sorbitol Liquid, Partially Dehydrated (E420)

Purified Water

Ponceau 4R (E124)

Lecithin (E322)

Triglycerides , medium chain

Ethanol

White ink*

The ink contains the following residual materials after application: Titanium Dioxide (E171), Polyvinyl Acetate Phthalate, Macrogol 400, ammonium hydroxide (E527), propylene glycol.

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Store below 25°C

6.5 Nature And Contents Of Container

Blisters formed from Opaque Duplex PVC/PVdC 250µm/60gsm heat sealed to 20µm aluminium foil

or

opaque Tristar (Triplex) PVC/PE/PVdC 250µm/25µm/90gsm heat sealed to 20µm aluminium foil packed into cartons

Each carton may contain 10, 12, 16 in blister strips

Not all packs will be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Crookes Healthcare Limited

1 Thane Road West

Nottingham

NG2 3AA

8. Marketing Authorisation Number(S)

PL 00327/0197

9. Date Of First Authorisation/Renewal Of The Authorisation

25/01/2008

10. Date Of Revision Of The Text

03/09/2010

Sulbactam Pivoxil

Sulbactam Pivoxil may be available in the countries listed below.

Ingredient matches for Sulbactam Pivoxil

Sulbactam

Sulbactam Pivoxil (USAN) is known as Sulbactam in the US.

International Drug Name Search

Glossary

USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Levogen

Levogen may be available in the countries listed below.

Ingredient matches for Levogen

Levofloxacin

Levofloxacin is reported as an ingredient of Levogen in the following countries:

• Bangladesh

International Drug Name Search