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Ralovera 5mg Tablets 56

IMPORTANT NOTE – A VALID AUSTRALIAN PRESCRIPTION IS REQUIRED BEFORE THIS ITEM CAN BE SHIPPED

Drug Name: medroxyprogesterone
Our Price $11.69
PBS $15.70
Concession $5.60
Safety Net $0.00

S8 Note - This prescription item is Schedule 8 and can only be supplied on a script from a registered doctor in Queensland. Any prescriptions from any other state cannot be filled and will be returned in the mail

Note: Private, PBS and our prices are available to the general public. Concession and Safety Net prices are only available to people with the appropriate concession or Safety Net cards. See Prescriptions for more details.

GOVERNMENT AUTHORITY SCRIPT

This prescription item requires a pre approved authority from the Government in order to get this item at the quoted price. Authority prescriptions need to be applied for by the doctor writing the script and can include reasons such as increased quantities due to dosage, increased repeats, use for a pre determined specified use, or the nature of the medication itself requiring specialist interaction. In the event that an authority is not granted on the script, the price will revert to the private price quoted for that item

WARNING - MULTIPLE PACK PRESCRIPTION - PLEASE READ CAREFULLY

This item contains more than one pack of a prescription product. Before this can be dispensed the doctor has to give approval. The prescription must be written for the total quantity or the prescription must be endorsed by your doctor "Regulation 24" otherwise we will be unable to dispense the increased amount. If you proceed with the order without approval, we will only send out one pack at the single pack price and refund the difference. Eg If your prescription is written out for 30 Tablets with 5 repeats and it does not have “Regulation 24 “ written on the script, the ONLY quantity we can dispense is 30 at one time. Further dispensing of this product could only occur after an appropriate length of time - usually 21 days but depends on dosage. In this example if you would like to obtain 180 Tablets then the doctor must endorse the prescription “Regulation 24” or the quantity must be written out for 180 and not 30. NB Conditions apply on the writing of a Regulation 24 prescription. Ask your doctor or pharmacist for details.

We can no longer accept signed authority forms from your doctor as permission to dispense more than one pack. Please contact our pharmacist for more information.

If you order this item as Private, NO PBS stickers will be issued. Once any prescription order has been sent the product cannot be returned for a refund even if your doctor changes your medication or you have an adverse reaction.

Ralovera 5mg Tablets 56

Ralovera 5mg Tablets 56

Product ID: 7355
$11.69

Pharmacist Only Medicine

This product is a Pharmacist Only Medicine and requires pharmacist advice before we can dispatch this product. You must first place the order and then contact our pharmacists within 48 hours on 1300 367 283. The pharmacist will determine if this product is appropriate for you and if so, approve the order. In the event that you do not do this, the product will be deleted from your order and the balance of your order will be dispatched. This is not required if you have a doctor's prescription.

 

General Information

onsumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about RALOVERA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking RALOVERA against the benefits it is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What RALOVERA is used for

RALOVERA is a progestogen that comes from progesterone, a natural sex hormone. RALOVERA works in a similar way to progesterone.

RALOVERA is used to treat:


1. Endometriosis - a condition in which tissue similar to the lining of the uterus (womb) grows outside the uterus, causing pain and bleeding. RALOVERA helps to stop the growth of this tissue.
2. Secondary amenorrhea (a lack of menstrual periods not due to pregnancy). RALOVERA, with or without an oestrogen, helps to re-establish a regular menstrual cycle.
3. Abnormal bleeding from the uterus, when the lining of the uterus breaks down during the menstrual cycle rather than at the end, resulting in vaginal spotting or bleeding. RALOVERA helps to re-establish a regular menstrual cycle.
4. Symptoms of menopause in women with an intact uterus. RALOVERA is used together with an oestrogen-containing medicine to protect the lining of the uterus while the oestrogen relieves the symptoms.

Ask your doctor if you have any questions about why RALOVERA has been prescribed for you. Your doctor may have prescribed it for another reason.

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

Before you take RALOVERA

When you must not take it

Do not take RALOVERA if you have an allergy to medroxyprogesterone acetate or any of the ingredients in RALOVERA listed at the end of this leaflet.

Do not take RALOVERA if you have or have had any of the following medical conditions:


a stroke, blood clots or pulmonary embolism
severe liver disease
unusual or irregular vaginal
bleeding or blood in your urine that has not been diagnosed by your doctor
bleeding or discharge from your nipples
breast cancer or breast lumps not diagnosed by your doctor
uncontrolled high blood pressure

Do not take RALOVERA if you have had your uterus removed.

Do not take RALOVERA if you are pregnant or suspect you may be pregnant. RALOVERA may affect your developing baby if you take it during pregnancy.

Do not take RALOVERA after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking RALOVERA, contact your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:


heart problems
kidney problems
migraine
unusual or irregular vaginal bleeding
genital or breast cancer
epilepsy
asthma
diabetes
depression

If you have not told your doctor about any of the above, tell him/her before you start taking RALOVERA.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines may interfere with RALOVERA. These include aminoglutethimide, a medicine used to treat breast cancer. This medicine may affect how well RALOVERA works. You may need different amounts of your medicine or you may need to take different medicines. Your doctor will advise you.

Your doctor or pharmacist may have more information on medicines to be careful with or avoid while taking RALOVERA.

How to take RALOVERA

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the label or in this leaflet, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how much RALOVERA to take. This will vary depending on the condition for which you are being treated. RALOVERA should be used at the lowest effective dose to treat your condition.

Your doctor may tell you to take RALOVERA every day or in repeating cycles with a break in between.

How to take RALOVERA

Swallow the tablets whole with a full glass of water.

When to take RALOVERA

Take RALOVERA at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How long to take it

Continue taking your medicine for as long as your doctor tells you. Your doctor will prescribe RALOVERA for the shortest duration necessary to effectively treat your condition.

If you forget to take RALOVERA

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking RALOVERA as you would normally.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital if you think you or anyone else may have taken too much RALOVERA. Do this even if there are no signs of discomfort or poisoning. You may need medical attention.

While you are taking RALOVERA

Things you must do

Take RALOVERA exactly as your doctor has prescribed.

Tell your doctor if you think you may have become pregnant during treatment.

RALOVERA should not be used during pregnancy.

Tell your doctor immediately if you have sudden partial or complete loss of vision or sudden onset of double vision or migraine. You will need to be examined and may need to stop taking your medicine.

Tell all doctors and pharmacists who are treating you that you are taking RALOVERA.

If you are about to start taking any new medicines, tell your doctor and pharmacist that you are taking RALOVERA.

If you are going to have any laboratory tests, tell your doctor that you are taking RALOVERA. RALOVERA may interfere with the results of some tests.

Tell your doctor if you feel that RALOVERA is not helping your condition.

Visit your doctor regularly.

Your doctor needs to check your progress and see whether you need to keep taking RALOVERA.

Regularly check your breasts for any lumps and have regular professional breast examinations and mammograms, as recommended by your doctor.

Tell your doctor if, for any reason, you have not taken RALOVERA exactly as prescribed.

Always discuss with your doctor any problems or difficulties during or after taking RALOVERA. Things you must not do

Do not change your dose or stop taking RALOVERA without first checking with your doctor.

Do not take RALOVERA to treat other complaints unless your doctor tells you to.

Do not give RALOVERA to anyone else, even if they have the same condition as you.

Things to be careful of

RALOVERA generally does not cause any problems with your ability to drive a car or operate machinery. However, RALOVERA may cause dizziness, drowsiness or fatigue in some people.

Make sure you know how you react to RALOVERA before driving a car or operating machinery.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking or soon after you are finished taking RALOVERA. RALOVERA helps most people for whom it is prescribed but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

If you are over 65 years of age you may have an increased chance of getting some side effects.

The use of an oestrogen at the same time as RALOVERA may also increase the risk of side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and it worries you:


nervousness or difficulty concentrating
difficulty sleeping or increased sleepiness, drowsiness or fatigue
depression or excitation
dizziness
headache
tremor
skin conditions, such as hives, itching, rash or acne
unusual hair loss or hair thinning or increased hairiness
sweating
irregular vaginal bleeding or spotting or unusual changes in vaginal secretions
lack of menstrual periods
nausea or vomiting
constipation or diarrhoea
dry mouth
breast tenderness
unusual secretion of breast milk
changes in sexual drive
fever
change in weight
yellowing of the skin or eyes
leg cramps
fluid retention

Tell your doctor as soon as possible if you notice the following:


confusion or memory loss
lumps or change in your breasts

Although these side effects are not common, they may require further medical assessment for serious conditions, such as dementia or breast cancer.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen:


painful swelling in a leg
chest pain or shortness of breath
severe headaches or changes in speech or vision
swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing

The above list includes side effects that may indicate serious conditions that require urgent medical attention or hospitalisation, such as blood clots, heart attack, stroke or severe allergic reactions. Such side effects are not common.

Other side effects not listed above may also occur in some patients.

Tell your doctor if you notice anything else that is making you feel unwell. Some side effects (such as changes in blood pressure) can only be found when your doctor does tests from time to time to check your progress.

After using RALOVERA

Storage

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.

Keep RALOVERA in a cool, dry place where the temperature stays below 30 °C.

Do not store RALOVERA, or any other medicine, in a bathroom or near a sink. Do not leave it in the car or on windowsills. Heat and dampness can destroy some medicines.

Keep your RALOVERA tablets where children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking RALOVERA, or it has passed its expiry date, ask your pharmacist what to do with any tablets left over.

Product description

What it looks like

RALOVERA tablets are available in 5 mg and 10 mg strengths.

RALOVERA 5 mg tablets are pale blue, round and flat, scored and marked "286" on one side and "U" on the other. The 5 mg tablets are available in blister packs of 56 tablets.

RALOVERA 10 mg tablets are white, round and convex, scored on one side and marked "UPJOHN 50" on the other. The 10 mg tablets are available in blister packs of 30 and bottles of 100.

Ingredients

The active ingredient in RALOVERA tablets is medroxyprogesterone acetate.

RALOVERA tablets also contain lactose, sucrose, maize-starch, liquid paraffin, purified talc and calcium stearate. RALOVERA 5 mg tablets also contain indigo carmine CI73015 as a colouring agent.

Supplier

RALOVERA tablets are supplied in Australia by:

Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114
Australia
Toll free number 1800 675 229
Australian Registration Numbers
5 mg blister: AUST R 46531
10 mg blister: AUST R 46532
10 mg bottle: AUST R 46534
This leaflet was revised on 4 July 2005.
© Copyright Pfizer Australia Pty Ltd 2003-2004
* Registered Trademark

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There is generic brand to choose from in the table below. Generic Brands are less expensive brands that have been proven to have the same effect. Please select the desired brand.* *Some Doctor's will have "no substitution permitted" endorsed on the script. Please check your prescription as generics are not available in this case.
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