Hydromol Cream (Alliance Pharmaceuticals)

1. Name Of The Medicinal Product

Hydromol Cream.

2. Qualitative And Quantitative Composition

Sodium Pyrrolidone Carboxylate 2.5%.

Excipients: Cetomacrogol emulsifying wax contains cetostearyl alcohol.

For full list of excipients see Section 6.1.

3. Pharmaceutical Form

Hydromol Cream is a soft, white, oil-in-water cream which can be massaged easily into the skin.

4. Clinical Particulars

4.1 Therapeutic Indications

Any condition in which “dry skin” is a feature, including all forms of dermatitis/eczema and all degrees of ichthyosis and senile pruritus.

4.2 Posology And Method Of Administration

Route of administration

For topical use only.

Adults, Children and the Elderly:

Apply liberally to the affected area and massage well into the skin. Hydromol Cream may be used as often as required.

Hydromol Cream is especially beneficial when used immediately after washing or bathing, when the resultant warmth of the skin enhances absorption.

4.3 Contraindications

There are no contra-indications except true hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

The formulation is not designed for use as a diluent.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Hydromol Cream is not contra-indicated in pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Rarely a non serious allergic type reaction may be experienced, e.g. rash.

4.9 Overdose

Not applicable. Hydromol Cream is for topical use only.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The combination of oils used in Hydromol Cream helps to lubricate and hydrate the skin. Moisture loss from the stratum corneum is reduced by the formation of an occlusive film by liquid paraffin on the surface of the skin. Isopropyl myristate, a fatty acid ester, is easily absorbed into the skin and helps to improve skin softness.

5.2 Pharmacokinetic Properties

Sodium pyrrolidone carboxylate positively aids the hydration of skin.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Liquid Paraffin

Isopropyl Myristate

Sodium Lactate

Cetomacrogol Emulsifying Wax (contains cetostearyl alcohol)

Myristyl Myristate

Cetomacrogol 1000

Hydroxybenzoates (Parabens)

Phenoxyethanol

Purified Water.

6.2 Incompatibilities

Not applicable. Hydromol Cream is for topical use only.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Hydromol Cream should be stored in a dry place avoiding extremes of temperature ie not less than 5°C and not more than 30°C.

6.5 Nature And Contents Of Container

Hydromol Cream is packed in low density polyethylene tubes of 10 g, 50 g and 100 g with a flush fitting cap. It is also available in polypropylene tubs containing 500 g with pump dispenser.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Ltd., Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB.

8. Marketing Authorisation Number(S)

PL 16853/0089.

9. Date Of First Authorisation/Renewal Of The Authorisation

1^st October 2004.

10. Date Of Revision Of The Text

20^th March 2009

Gralise

Pronunciation: GAB-a-PEN-tin
Generic Name: Gabapentin
Brand Name: Gralise

Gralise is used for:

Treating nerve pain caused by shingles. It may also be used for other conditions as determined by your doctor.

Gralise is an analgesic for neuropathic (nerve) pain. Exactly how it works to treat nerve pain is not known.

Do NOT use Gralise if:

• you are allergic to any ingredient in Gralise


• you have severe kidney problems or are on dialysis

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

Before using Gralise:

Some medical conditions may interact with Gralise. 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 kidney problems


• if you have a history of seizures, mental or mood problems (eg, depression), or suicidal thoughts or actions

Tell your health care provider if you are taking any medicines, especially any of the following:

• Morphine or naproxen because they may increase the risk of Gralise's side effects, including drowsiness


• Hydrocodone because its effectiveness may be decreased by Gralise

This may not be a complete list of all interactions that may occur. Ask your health care provider if Gralise 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 Gralise:

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

• Gralise comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Gralise refilled.


• Take Gralise by mouth with the evening meal, unless directed otherwise by your doctor.


• Swallow Gralise whole. Do not break, crush, or chew before swallowing.


• Do not take an antacid that has aluminum or magnesium in it within 2 hours before you take Gralise.


• Gralise works best if it is taken at the same time each day.


• Do not suddenly stop taking Gralise. You may experience side effects such as anxiety, insomnia, nausea, pain, and sweating. Patients with seizure disorder may also experience increased seizures. If you need to stop Gralise or add a new medicine, your doctor will gradually lower your dose.


• If you miss a dose of Gralise, take it with food 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 Gralise.

Important safety information:

• Gralise may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Gralise 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 or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Gralise; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not change your dose of Gralise without checking with your doctor.


• Do not switch between Gralise and other gabapentin products without first checking with your doctor.


• Patients who take Gralise may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Gralise closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


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


• Gralise may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Gralise.


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


• Use Gralise with caution in the ELDERLY; they may be more sensitive to its effects, especially swelling of the hands, legs, or feet.


• Gralise should be used with extreme caution in CHILDREN; safety and effectiveness in 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 taking Gralise while you are pregnant. Gralise is found in breast milk. If you are or will be breast-feeding while you take Gralise, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Gralise:

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:

Diarrhea; dizziness; drowsiness; dry mouth; tiredness.

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); behavior changes; confusion; difficult or painful urination; fever; memory problems; new or worsening mental or mood changes (eg, depression, agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, inability to sit still); new or worsening trouble sleeping; red, swollen, blistered, or peeling skin; severe headache or dizziness; suicidal thoughts or actions; swelling of the hands, legs, or feet.

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: Gralise 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 diarrhea; double vision; drowsiness; sluggishness; slurred speech.

Proper storage of Gralise:

Store Gralise at 77 degrees F (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 Gralise out of the reach of children and away from pets.

General information:

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


• Gralise 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 Gralise. 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 Gralise resources

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

• Gralise Consumer Overview


• Gralise Prescribing Information (FDA)


• Gralise Advanced Consumer (Micromedex) - Includes Dosage Information


• Gabapentin Prescribing Information (FDA)


• Gabapentin Professional Patient Advice (Wolters Kluwer)


• Gabapentin Monograph (AHFS DI)


• Horizant Prescribing Information (FDA)


• Horizant Consumer Overview


• Neurontin Prescribing Information (FDA)


• Neurontin Consumer Overview

Compare Gralise with other medications

• Persisting Pain, Shingles

Iressa

Pronunciation: geh-FIT-in-ib
Generic Name: Gefitinib
Brand Name: Iressa

Iressa is used for:

Treating non-small cell lung cancer after other cancer chemotherapy treatments have not been successful. It may also be used for other conditions as determined by your doctor.

Iressa is a cancer chemotherapy agent. It works by blocking a certain protein (an enzyme called tyrosine kinase). This helps to stop the cancer from growing and spreading.

Do NOT use Iressa if:

• you are allergic to any ingredient in Iressa

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

Before using Iressa:

Some medical conditions may interact with Iressa. 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 lung disease (eg, pulmonary fibrosis), heart problems, severe kidney problems, or liver problems


• if you have had a stroke

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

• Antacids (eg, sodium bicarbonate, calcium carbonate), histamine H₂-receptor blockers (eg, famotidine), hydantoins (eg, phenytoin), or rifampin because the effectiveness of Iressa may be decreased


• Imidazoles (eg, ketoconazole) because the side effects of Iressa may be increased


• Anticoagulants (eg, warfarin) because the risk of bleeding may be increased


• Vinorelbine because the risk of low white blood cell counts may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Iressa 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 Iressa:

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

• Iressa may be taken with or without food.


• If you have difficulty swallowing the tablet, it can be added to half a glass of water (non-carbonated). Do not use other liquids. Drop the tablet into the water, without crushing it, and stir until it dissolves (about 10 minutes). Then drink the liquid immediately. Rinse the glass with half a glass of water and drink it.


• Take Iressa regularly to receive the most benefit from it.


• Taking Iressa at the same time each day will help you remember to take it.


• If you miss a dose of Iressa, 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 Iressa.

Important safety information:

• Additional monitoring of your dose or condition may be needed if you are taking erythromycin, clarithromycin, or St. John's wort.


• Iressa may cause changes in vision. Contact your doctor if eye irritation occurs. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Iressa.


• LAB TESTS, including liver function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Iressa is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not become pregnant while taking Iressa. Iressa may cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Iressa during pregnancy. It is unknown if Iressa is excreted in breast milk. Do not breast-feed while taking Iressa.

Possible side effects of Iressa:

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:

Acne; diarrhea; dry skin; loss of appetite; mouth ulcers; nausea; unusual weakness; vision problems; vomiting; weight loss.

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 eyelids, mouth, face, lips, or tongue); cough; dark urine; dizziness; eye irritation or pain; extreme fatigue; fever; persistent diarrhea; stomach pain; swelling of the ankles or feet; yellowing of the skin or eyes.

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: Iressa 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 severe or persistent diarrhea; severe skin rash.

Proper storage of Iressa:

Store Iressa at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Iressa out of the reach of children and away from pets.

General information:

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


• Iressa 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 Iressa. 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 Iressa resources

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

• Iressa Prescribing Information (FDA)


• Iressa Monograph (AHFS DI)


• Iressa Advanced Consumer (Micromedex) - Includes Dosage Information


• Iressa Consumer Overview

Compare Iressa with other medications

• Non-Small Cell Lung Cancer

Protirelin Ampoules (Cambridge Laboratories)

What you should know about Protirelin Ampoules

This leaflet contains information about Protirelin Ampoules, which are administered by a doctor or nurse as part of the test you are about to have done. Although you will not be taking this medicine or giving it to your child yourself, this leaflet contains important information to help you understand how Protirelin is used. If there is anything you do not understand, please ask a doctor or nurse.

This leaflet is written for the patient who is to have the test. If you are the parent of a child who is going to have the test, then of course the information should be read as applying to the child.

What do Protirelin Ampoules contain?

Each ampoule contains 200micrograms of Protirelin (the active ingredient) together with some other ingredients which are as follows:

Mannitol Ph.Eur, Glacial Acetic Acid Ph.Eur, Water for Injections Ph.Eur

Protirelin Ampoules, coded with orange and black colour rings contain 2ml of a solution for injections. The solution contains 100micrograms of Protirelin per ml and is supplied in packs of 10 ampoules.

Protirelin is a diagnostic agent, which means that it is used in tests rather than as a treatment for a disease. The active ingredient of Protirelin Ampoules (Protirelin, also known as TRH) is a hormone which is produced by a part of the brain called the hypothalamus and acts on the pituitary gland which is situated very close to the hypothalamus. Protirelin causes the pituitary gland to release another hormone which in turn travels round in the blood stream and acts on another gland, the thyroid gland in the neck. The thyroid gland itself produces more hormones which help to control the body's metabolism - the chemical reactions that are going on inside us all the time.

The holder of the product licence for this medicine is

Cambridge Laboratories Limited

Deltic House

Kingfisher Way

Silverlink Business Park

Wallsend

Tyne & Wear

NE28 9NX

The ampoules are made by

BCM Limited

1 Thane Road

Nottingham

NG2 3AA

What is Protirelin used for?

Protirelin is used mainly to assess the functioning of the pituitary and thyroid glands. The test using this medicine can help to identify certain medical conditions involving these glands or, if you are already receiving treatment for such a disorder, that the correct dose of medicine is being used. In particular, Protirelin is used to test for overactivity of the thyroid, including the condition known as Grave's disease which causes the eyeballs to protrude, underactivity of the thyroid gland, underactivity of the pituitary gland and diseases of the hypothalamus.

What should I tell the doctor before the test?

You should inform the doctor if you suffer from any of the following:

• asthma


• any other condition causing difficulty in breathing


• heart disease


• any disorder of the pituitary gland

You should also tell the doctor if you are taking any medication (either prescribed or bought 'over the counter'). A number of other medicines can interfere with the results of this test, in particular the following:

• drugs which act on the thyroid gland


• steroids


• oestrogens (such as are present in some contraceptive pills)


• theophylline (a drug for asthma)


• levodopa and bromocriptine (for Parkinson's disease)


• major tranquillisers of the phenothiazine group (such as chlorpromazine), used for mental disorders


• metoclopramide (for nausea and vomiting)


• aspirin


• amiodarone (for disorders of the heart rhythm)


• carbamazepine (for epilepsy)


• lithium (for mental illness)

WOMEN: Please let the doctor know if you are pregnant. Although no harmful effects on the unborn child are known, the doctor may prefer to put off the test until after the baby has been born. If you are breastfeeding, you may notice extra swelling of the breasts and leaking of milk for up to three days after the test.

How are Protirelin Ampoules used?

Please ensure that you follow any instructions given by your doctor in preparation for the test (for example, not eating anything) carefully.

A blood sample will be taken first so that the amount of thyroid hormones in the blood can be measured. An injection of Protirelin will then be given into a vein (the normal adult dose is one ampoule or 200micrograms; a lower dose of 1microgram per kilogram of bodyweight is usually used in children) and another blood sample taken twenty minutes later. A further sample may be taken an hour after the injection if necessary.

Side-effects

It is unlikely that you (or your child if he or she is having this test) will experience any side-effects from the use of Protirelin. If any do occur, they should be mild and of short duration. The most likely are nausea, a desire to pass water, a feeling of flushing, slight dizziness, a brief rise in pulse rate and blood pressure and a peculiar taste.

If these do occur and you are concerned about them, or if you think that Protirelin has caused any other side-effect, please tell your doctor or nurse about it.

This medicine should not be used after the expiry date that is shown on the carton.

All medicines should be kept out of the reach of children.

Date of preparation of this leaflet: October 2002

Aqueous Cream BP (Boots Company plc)

1. Name Of The Medicinal Product

Aqueous Cream B.P.

2. Qualitative And Quantitative Composition

Active ingredient	% w/w
White Soft Paraffin BP Liquid Paraffin BP	15.0 6.0

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of dry skin disorders.

For topical application to the skin.

4.2 Posology And Method Of Administration

Adults, children and elderly:

To be applied to the skin as required.

May also be used as a soap substitute.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

For external use only.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant drug interactions known.

4.6 Pregnancy And Lactation

The safety of aqueous cream during pregnancy and lactation has not been established but is not considered to constitute a hazard during these periods.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Occasional hypersensitivity reactions.

4.9 Overdose

Symptoms of accidental oral ingestion may include gastrointestinal symptoms, particularly diarrhoea. Treatment need only be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

White soft paraffin and liquid paraffin have emollient properties.

5.2 Pharmacokinetic Properties

None applicable.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Emulsifying wax

Chlorocresol

Purified water

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Tub: Store in a cool place.

Tube: None

6.5 Nature And Contents Of Container

Polypropylene jar with an unlined polypropylene cap.

Pack size 500g.

or Polypropylene securitub with a white pilfer-proof polythene cap.

Pack size: 500g

or Pigmented LDPE/HDPE tube fitted with a polypropylene screw cap.

Pack sizes: 60g, 100g

or Laminate tube fitted with a polypropylene screw cap.

Pack sizes: 60g, 100g

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

The Boots Company PLC

Nottingham

NG2 3AA

Trading as: BCM

8. Marketing Authorisation Number(S)

PL 00014/5202R

9. Date Of First Authorisation/Renewal Of The Authorisation

First Authorisation: 16 December 1986

Renewal: 16 December 1991

10. Date Of Revision Of The Text

June 2009

Zavesca

Generic Name: miglustat (Oral route)

mi-GLOO-stat

Commonly used brand name(s)

In the U.S.

• Zavesca

Available Dosage Forms:

• Capsule

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Glucosylceramide Synthase Inhibitor

Uses For Zavesca

Miglustat is used to treat adults with mild to moderate type 1 Gaucher disease. Miglustat is only used in people who cannot be treated with enzyme replacement therapy. Type 1 Gaucher disease is a disease you get from both your parents. People with type 1 Gaucher disease are missing an enzyme (naturally occurring substance in your body) that breaks down a chemical in your body called glucosylceramide. Too much glucosylceramide causes liver and spleen enlargement, changes in the blood, and bone disease. Miglustat works by stopping the body from making glucosylceramide.

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

Before Using Zavesca

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

This medicine is not used in children under 18 years of age.

Geriatric

Many medicines have not been specifically studied in older people. Therefore, it may not be known whether they work the same way the do in younger adults. This medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Gaucher disease, Type 1, severe—this medicine is not currently being used in patients with severe Type 1 Gaucher disease

• Kidney disease—this condition may cause you to have more miglustat in your body; your doctor may want to change the amount of miglustat that you take

Proper Use of Zavesca

It is important to take miglustat exactly as your doctor prescribed. You should take your medicine at the same time or at the same times each day.

The capsules should be swallowed whole with water and may be taken with or without food. Check with your doctor or pharmacist if you have any questions.

Your doctor may recommend changes to your diet to help with some side effects. It is important that you follow these changes.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  
  • For Mild to Moderate Type 1 Gaucher disease
    
    • Adults—One 100 milligram (mg) capsule given three times a day; your doctor may change this dose as needed
    
    
    • Children—Use is not recommended in children under the age of 18
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Zavesca

Miglustat can cause problems affecting your nerves. If you have hand tremors (shaky movements) or if miglustat worsens a hand tremor you already have call your doctor. Your doctor might want to change your dose of miglustat.

If you experience numbness and tingling in your hands, arms, legs, or feet (peripheral neuropathy) call your doctor right away.

It is very important that your doctor check you at regular visits. Your doctor will also want to test your nerves (neurological exam) before you start taking miglustat and may repeat this test at a later time.

Diarrhea is the most common side effect for people taking miglustat. Your doctor may give you another medicine (anti-diarrheal) to help treat diarrhea if it is a problem for you. Your doctor may also recommend changes to your diet. You may also lose weight when you start treatment with miglustat.

It is very important to discuss with your doctor if you are pregnant or plan to become pregnant before starting miglustat. You should use effective birth control while taking miglustat. Miglustat may also harm a man's sperm. All men should use effective birth control during treatment and for three months after stopping treatment.

Zavesca 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 immediately if any of the following side effects occur:

More common

• Black, tarry stools


• bleeding gums


• blood in urine or stools


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• pinpoint red spots on skin


• unusual bleeding or bruising

Unknown

• Painful sensations


• shakiness in legs, arms, hands, feet


• trembling or shaking of hands or feet


• unsteadiness or awkwardness


• weakness in arms, hands, legs, or feet

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

• Acid or sour stomach


• back pain


• belching


• bloated, full feeling


• change in vision


• cramps


• diarrhea


• difficulty having a bowel movement (stool)


• dizziness


• dry mouth


• excess air or gas in stomach or intestines


• full or bloated feeling or pressure in the stomach


• headache


• heartburn


• heaviness in limbs


• indigestion


• leg cramps


• loss of appetite


• memory loss


• menstrual changes


• nausea


• pain or discomfort in chest, upper stomach, or throat


• passing gas


• stomach discomfort, upset or pain


• swelling


• swelling of abdominal or stomach area


• unsteady walk


• vomiting


• weakness


• weight loss

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: Zavesca 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 Zavesca resources

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

• Zavesca Prescribing Information (FDA)


• Zavesca Consumer Overview


• Zavesca Monograph (AHFS DI)


• Zavesca MedFacts Consumer Leaflet (Wolters Kluwer)


• Miglustat Professional Patient Advice (Wolters Kluwer)

Compare Zavesca with other medications

• Gaucher Disease

Boots Hayfever Relief Eye Drops

1. Name Of The Medicinal Product

Sodium Cromoglicate Eye Drops 2% w/v

Pollenase Allergy Eye Drops

Lloyds Pharmacy Allergy Relief Eye Drops

Vantage Allergy Eye Drops

Boots Hayfever Relief Eye Drops

2. Qualitative And Quantitative Composition

Sodium cromoglicate BP (equivalent to anhydrous sodium cromoglicate)

3. Pharmaceutical Form

Eye drops

4. Clinical Particulars

4.1 Therapeutic Indications

A) 13.5m1 packs:	(POM): For the relief and treatment of acute allergic conjunctivitis such as hayfever, chronic allergic conjunctivitis and vernal kerato conjunctivitis.
B) 5m1 and 10ml packs:	(P): For the treatment of Hayfever

4.2 Posology And Method Of Administration

Adults and Children:

One or two drops to be administered into each eye four times daily, or as prescribed by the doctor.

Elderly:

There is no evidence to suggest that dosage alteration is required for elderly patients.

4.3 Contraindications

Known hypersensitivity to any ingredient, including sodium cromoglicate, benzalkonium chloride and disodium edetate.

4.4 Special Warnings And Precautions For Use

Soft contact lenses should not be worn during treatment with Sodium Cromoglicate Eye Drops.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Cumulative experience with sodium cromoglicate suggests that it has no adverse effects on foetal development. However, as with all medicines, caution should be exercised during pregnancy, and it should be used in pregnancy only when there is a clear need.

4.7 Effects On Ability To Drive And Use Machines

Instillation may cause transient blurring of vision. Do not drive or operate machinery if affected.

4.8 Undesirable Effects

Transient stinging and blurring of vision may occur. Other symptoms of local irritation have been reported rarely.

4.9 Overdose

Overdosage is very unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The solution exerts its effect locally in the eye.

Sodium cromoglicate inhibits the release from sensitised mast cells of mediators of the allergic reaction.

5.2 Pharmacokinetic Properties

Limited systemic absorption may be expected via the occular mucosa.

Sodium cromoglicate is not metabolised.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Disodium edetate

Benzalkonium chloride

Water

6.2 Incompatibilities

None known

6.3 Shelf Life

24 months unopened – 28 days opened.

6.4 Special Precautions For Storage

Store below 25°C, protected from direct sunlight.

6.5 Nature And Contents Of Container

White polyethylene bottles fitted with integral dropper and closed with a polypropylene or polyethylene screw cap containing 5 or 10ml eye drops.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

PLIVA Pharma Ltd.

Ridings Point

Whistler Drive

Castleford

WF10 5HX

8. Marketing Authorisation Number(S)

PL 10622/0016

9. Date Of First Authorisation/Renewal Of The Authorisation

19th January 2000 (Renewal)

10. Date Of Revision Of The Text

13th September 2011