Levofloxacin Drops

Pronunciation: LEE-voe-FLOX-a-sin
Generic Name: Levofloxacin
Brand Name: Iquix

Levofloxacin Drops are used for:

Treating corneal ulcers caused by bacteria sensitive to Levofloxacin Drops. It may also be used for other conditions as determined by your doctor.

Levofloxacin Drops are a fluoroquinolone eye drop. It works by blocking bacteria from reproducing in the eye.

Do NOT use Levofloxacin Drops if:

• you are allergic to any ingredient in Levofloxacin Drops or to any other fluoroquinolone antibiotic (eg, ciprofloxacin, gatifloxacin)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Levofloxacin Drops:

Some medical conditions may interact with Levofloxacin Drops. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Levofloxacin Drops. Because little, if any, of Levofloxacin Drops are absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Levofloxacin Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Levofloxacin Drops:

Use Levofloxacin Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Levofloxacin Drops are only for the eye. Do not get it in your nose or mouth.


• To use Levofloxacin Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.


• Do not wear contact lenses while you are using Levofloxacin Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.


• Levofloxacin Drops works best if it is used at the same time each day.


• To clear up your infection completely, use Levofloxacin Drops for the full course of treatment. Keep using it even if you feel better in a few days.


• Do not miss any doses of Levofloxacin Drops. If you miss a dose of Levofloxacin Drops, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Levofloxacin Drops.

Important safety information:

• Levofloxacin Drops may cause blurred vision. This effect may be worse if you take it with alcohol or certain medicines. Use Levofloxacin Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Be sure to use Levofloxacin Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Levofloxacin Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• If you notice vision changes, vaginal irritation or itching, or white patches in your mouth, contact your doctor at once.


• Diabetes patients - Levofloxacin Drops may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Levofloxacin Drops should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Levofloxacin Drops while you are pregnant. Levofloxacin Drops are found in breast milk. If you are or will be breast-feeding while you take Levofloxacin Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Levofloxacin Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; headache; strange taste.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); double vision or other vision changes; eye itching or pain; eye or eyelid swelling.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Levofloxacin Drops:

Store Levofloxacin Drops at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Levofloxacin Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Levofloxacin Drops, please talk with your doctor, pharmacist, or other health care provider.


• Levofloxacin Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Levofloxacin Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Levofloxacin resources

• Levofloxacin Use in Pregnancy & Breastfeeding
• Levofloxacin Support Group
• 0 Reviews for Levofloxacin - Add your own review/rating

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Propranolol Solution

Pronunciation: proe-PRAN-oh-lol
Generic Name: Propranolol
Brand Name: Generic only. No brands available.

Do not suddenly stop taking Propranolol Solution. Sharp chest pain, irregular heartbeat, and, sometimes, heart attack may occur if you suddenly stop Propranolol Solution. The risk may be greater if you have certain types of heart disease. Your doctor should slowly lower your dose over several weeks if you need to stop taking Propranolol Solution. This should be done even if you only take Propranolol Solution for high blood pressure. Heart disease is common and you may not know you have it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Propranolol Solution again.

Propranolol Solution is used for:

Treating high blood pressure or certain types of irregular heartbeat. It is used in patients with angina to decrease angina frequency and increase exercise tolerance. It is used to decrease the risk of heart death in certain patients who have survived a heart attack. It is used to manage certain types of tremors, a heart condition called hypertrophic subaortic stenosis, or certain symptoms of pheochromocytoma (an adrenal gland tumor). It is also used to prevent migraine headaches. It may also be used for other conditions as determined by your doctor.

Propranolol Solution is a beta-blocker. It works by slowing down the heart and decreasing the amount of blood it pumps out. This decreases blood pressure, helps the heart pump more efficiently, and reduces the workload on the heart. Exactly how Propranolol Solution works to treat migraines or tremors is not known.

Do NOT use Propranolol Solution if:

• you are allergic to any ingredient in Propranolol Solution


• you have moderate to severe heart block, sick sinus syndrome, or a very slow heartbeat and you do not have a permanent pacemaker


• you have uncontrolled heart failure or shock caused by serious heart problems


• you have asthma


• the patient is a child with diabetes or heart failure


• you are taking mibefradil

Contact your doctor or health care provider right away if any of these apply to you.

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Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using Propranolol Solution:

Some medical conditions may interact with Propranolol Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of other heart problems (eg, angina, congestive heart failure, slow heartbeat)


• if you have a history of liver or kidney problems, blood vessel disease, lung or breathing problems (eg, chronic bronchitis, chronic obstructive pulmonary disease [COPD], emphysema), diabetes, low blood sugar, overactive thyroid, or glaucoma


• if you have Wolff-Parkinson-White syndrome, Down syndrome, Raynaud syndrome, or an adrenal gland tumor (pheochromocytoma)


• if you smoke or drink alcohol


• if you are scheduled to have surgery or receive anesthesia

Some MEDICINES MAY INTERACT with Propranolol Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Mibefradil because the risk of serious heart side effects may be increased


• Diphenhydramine because it may increase the risk of Propranolol Solution's side effects. Before you start any new medicine, including over-the-counter medicines, check the label to see if it contains diphenhydramine. If it does or you are not sure, check with doctor or pharmacist


• Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, high blood pressure, heart problems, irregular heartbeat, diabetes, prostate problems, blood thinning, thyroid problems, depression, mental or mood problems, immune system suppression, allergic reactions, asthma or other lung or breathing problems, high cholesterol, seizures, multiple sclerosis [MS]), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Propranolol Solution, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Propranolol Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Propranolol Solution:

Use Propranolol Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Propranolol Solution by mouth. Talk to your doctor about how you should take it with regard to food.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you are taking an antacid with aluminum in it, take it at least 2 hours after you take Propranolol Solution.


• Take Propranolol Solution on a regular schedule to get the most benefit from it. Taking Propranolol Solution at the same time each day will help you remember to take it.


• Continue to take Propranolol Solution even if you feel well. Do not miss any doses.


• Do not suddenly stop taking Propranolol Solution. You may have an increased risk of side effects. If you need to stop Propranolol Solution, your doctor will gradually lower your dose.


• If you miss a dose of Propranolol Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Propranolol Solution.

Important safety information:

• Propranolol Solution may cause drowsiness, dizziness, light-headedness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Propranolol Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before you drink alcohol while you are taking Propranolol Solution; it may increase the risk of Propranolol Solution's side effects.


• Do NOT take more than the recommended dose, change your dose, or stop taking Propranolol Solution without checking with your doctor. When taking Propranolol Solution for high blood pressure, it may take a few days to several weeks to receive the full benefits from Propranolol Solution.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Tell your doctor or dentist that you take Propranolol Solution before you receive any medical or dental care, emergency care, or surgery.


• If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk of an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are using Propranolol Solution.


• Propranolol Solution may lower your blood sugar levels. This is most likely to happen in infants and children or in patients who have diabetes or kidney problems. It may also occur after prolonged physical activity or during fasting. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. If this occurs, eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens.


• Diabetes patients - Propranolol Solution may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Propranolol Solution may interfere with certain lab tests, including glaucoma screening and dobutamine stress echocardiography. Be sure your doctor and lab personnel know you are taking Propranolol Solution.


• Lab tests, including blood pressure and heart function, may be performed while you use Propranolol Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Propranolol Solution with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Propranolol Solution in CHILDREN; they may be more sensitive to its effects, especially low blood sugar levels, certain heart problems, or shortness of breath.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Propranolol Solution while you are pregnant. Propranolol Solution is found in breast milk. If you are or will be breast-feeding while you use Propranolol Solution, check with your doctor. Discuss any possible risks to your baby.

If you stop taking Propranolol Solution suddenly, you may have WITHDRAWAL symptoms. These may include worsening chest pain along with possible heart attack.

Possible side effects of Propranolol Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; fatigue; light-headedness; nausea; stomach upset or cramping; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; fever with aching and sore throat; hallucinations; irregular heartbeat; memory loss; mental or mood changes (eg, depression); numbness or tingling of the hands; red, swollen, blistered, or peeling skin; severe or persistent dizziness or light-headedness; shortness of breath or wheezing; sudden, unusual weight gain; swelling of the hands, ankles, or feet; unusual bruising or bleeding; unusually slow heartbeat; very cold or blue fingers or toes; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Propranolol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; severe dizziness or light-headedness; shortness of breath; swelling of the hands, ankles, or feet; trouble breathing; very slow heart rate.

Proper storage of Propranolol Solution:

Store Propranolol Solution between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Propranolol Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Propranolol Solution, please talk with your doctor, pharmacist, or other health care provider.


• Propranolol Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Propranolol Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Propranolol resources

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

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• Tardive Dyskinesia
• Thyrotoxicosis

Paracetamol 120mg / 5ml Oral Suspension

1. Name Of The Medicinal Product

Paracetamol 120mg/5ml Oral Suspension

2. Qualitative And Quantitative Composition

Paracetamol (micronised) 120mg/5ml

3. Pharmaceutical Form

Oral Suspension

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of mild to moderate pain, including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains.

For the reduction of fever and to be used as an adjunctive treatment to relieve symptoms of cold and flu.

4.2 Posology And Method Of Administration

For oral administration only

Recommended doses:

		120 mg/5ml
CHILDREN	3 - 12 months	2.5 - 5ml
	1 - 5 years	5 - 10ml
	6 - 12 years	10 - 20ml

These doses may be repeated every 4 - 6 hours when necessary with a maximum of 4 doses in 24 hours.

Adults and children over 12: 20 - 40ml every 4 - 6 hours to a maximum of 4g daily.

If pyrexia develops after immunisation, a child can be given a dose of Paracetamol followed, if necessary, by a second dose 4 - 6 hours later. The dose of Paracetamol for post immunisation pyrexia in an infant aged 2 - 3 months is 60mg (2.5ml of the 120mg/5ml presentation); an oral syringe can be obtained from any Pharmacy to give the small dose volume required. The parents should be warned that if the pyrexia persists after the second dose medical advice should be sought.

4.3 Contraindications

Hypersensitivity to paracetamol and/or other constituents.

Patients with severe hepatic dysfunction.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Do not give with any other paracetamol-containing products.

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed serious liver damage.

Do not exceed the recommended dose.

If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

Excipients in the formulation

This product contains hydroxybenzoates. These may cause allergic reactions (possibly delayed). The product also contains sucrose (3g per 5ml dose) and sorbitol. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The hepatotoxicity of Paracetamol, particularly after overdosage, may be increased by drugs which induce liver microsomal enzymes such as barbiturates, tricyclic antidepressants, and alcohol.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Antivirals: Regular use of Paracetamol possibly reduces metabolism of Zidovudine (increased risk of neutropenia).

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Paracetamol is excreted in breast milk but not in clinically significant quantities. Available published data do not contraindicate breast feeding.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causality related to paracetamol.

Cases of acute pancreatitis have been reported. Paracetamol has been widely used and reports of adverse reactions are rare, and are generally associated with overdosage.

Allergic reactions occur occasionally.

Nephrotoxic effects are uncommon and have not been reported in association with therapeutic doses, except after prolonged administration.

4.9 Overdose

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors

If the patient

a) Is on long term treatment wih carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

b) Regularly consumes ethanol in excess of recommended amounts

Or

c) Is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required, the patient should be given intravenous N-acetylcysteine in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and, to a lesser extent, through a peripheral action by blocking pain impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.

Paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat regulating centre to produce peripheral vaso-dilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

5.2 Pharmacokinetic Properties

Oral absorption is rapid and almost complete, it may be decreased if Paracetamol is taken following a high carbohydrate meal.

There is no significant protein binding with doses producing plasma concentrations of below 60mcg (µg)/ml, but may reach moderate levels with high or toxic doses.

Approximately 90 - 95% of a dose is metabolised in the liver, primarily by conjugation with glucuronic acid, sulphuric acid and cysteine. An intermediate metabolite, which may accumulate in overdosage after primary metabolic pathways become saturated, is hepatotoxic and possibly nephrotoxic.

Half life is 1 to 4 hours; does not change with renal failure but may be prolonged in acute overdosage, in some forms of hepatic disease, in the elderly, and in the neonate; may be somewhat shortened in children.

Time to peak concentration, 0.5 - 2 hours; peak plasma concentrations, 5 - 20mcg (µg)/ml (with doses up to 650mg); time to peak effect, 1- 3 hours; duration of action, 3- 4 hours.

Elimination is by the renal route, as metabolites, primarily conjugates, 3% of a dose may be excreted unchanged.

Peak concentration of 10 - 15mcg(µg)/ml have been measured in breast milk, 1 - 2 hours following maternal ingestion of a single 650mg dose. Half life in breast milk is 1.35 - 3.5 hours.

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars

6.1 List Of Excipients

Propylene glycol, methyl hydroxybenzoate, propyl hydroxybenzoate, xanthan gum, sorbitol solution 70%, sucrose, mango flavour 545329E and purified water.

6.2 Incompatibilities

None stated

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Store below 25°C. Protect from light

6.5 Nature And Contents Of Container

Amber (Type III) glass bottle with capacity of 60ml, 100ml, 125ml, 500ml and 1000ml.

Closure:

1. Aluminium, wadded, roll-on, pilfer proof closure. 2. HDPE, child resistant, tamper evident, EPE wadded closure 3. HDPE, tamper evident, EPE wadded closure.

6.6 Special Precautions For Disposal And Other Handling

None

Administrative Data

7. Marketing Authorisation Holder

Rosemont Pharmaceuticals Ltd

Rosemont House

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

8. Marketing Authorisation Number(S)

PL 0427/0077

9. Date Of First Authorisation/Renewal Of The Authorisation

11 January 1995

10. Date Of Revision Of The Text

Oct 2009