Medication Guide App

RAZYLAN 60MG FILM COATED TABLETS

Active substance: RALOXIFENE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Razylan 60mg film-coated tablets
(raloxifene hydrochloride)
Please read this information carefully before you start to take your medicine.
• Keep this leaflet until you have finished this pack as you may want to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the
same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Razylan is and what it is used for
2. Before you take Razylan
3. How to take Razylan
4. Possible side effects
5. How to store Razylan
6. Further information

1. WHAT RAZYLAN IS AND WHAT IT IS USED FOR
Razylan belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs). When a
woman reaches the menopause, the level of the female sex hormone oestrogen goes down. Razylan mimics some of the helpful
effects of oestrogen after the menopause.
Razylan is used to treat and prevent osteoporosis in postmenopausal women. Razylan reduces the risk of vertebral fractures in
women with postmenopausal osteoporosis. A reduction in the risk of hip fractures has not been shown.
Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after
the menopause. Although it may have no symptoms at first, osteoporosis makes you more likely to break bones, especially in
your spine, hips and wrists and may cause back pain, loss of height and a curved back.

2. BEFORE YOU TAKE RAZYLAN
Do not take Razylan:
• If you are allergic (hypersensitive) to raloxifene or any of the ingredients of Razylan.
• If there is a possibility that you can get pregnant, Razylan could harm your unborn baby.
• If you are being treated or have been treated for blood clots (deep vein thrombosis, pulmonary embolism or retinal
vein thrombosis).
• If you have liver disease (examples of liver disease include cirrhosis, mild hepatic impairment or cholestatic jaundice).
• If you have any unexplained vaginal bleeding. This must be investigated by your doctor.
• If you have active uterine cancer, as there is insufficient experience of Razylan use in women with this disease.
• If you have severe kidney problems.
Take special care with Razylan:
The following are reasons why this product may not be suitable for you. If any of them apply to you, talk to your doctor before
you take the medicine.
• If you are immobilised for some time such as being wheel-chair bound, needing to be admitted to a hospital or having to
stay in bed while recovering from an operation or an unexpected illness.
• If you are receiving oral oestrogen therapy.
• If you are suffering from breast cancer, as there is insufficient experience of Razylan use in women with this disease.
• If you have had a cerebrovascular accident (e.g. stroke), or if your doctor has told you that you are at high risk of having one.
It is unlikely that Razylan will cause vaginal bleeding, so any vaginal bleeding while you take Razylan is unexpected. You should
have this investigated by your doctor.
Razylan does not treat postmenopausal symptoms, such as hot flushes.
Razylan lowers total cholesterol and LDL (‘bad’) cholesterol. In general, it does not change triglycerides or HDL (‘good’)
cholesterol. However, if you have taken oestrogen in the past and had extreme elevations in triglycerides, you should talk to
your doctor before taking Razylan.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained
without a prescription.
If you are taking digoxin for your heart or anticoagulants like warfarin to thin your blood, your doctor may need to adjust your
dose of these medicines.
Tell your doctor if you are taking cholestyramine which is mainly used as lipid-lowering medicine.
You should not take cholestyramine at the same time as raloxifene as it may reduce the absorption of raloxifene.
Pregnancy and breast-feeding
Razylan is for use only by postmenopausal women and must not be taken by women who could still have a baby. Razylan could
harm your unborn child.
Do not take Razylan if you are breast-feeding as it might be excreted in mother's milk.
Driving and using machines
Razylan has no known effects on driving or using machines.
Important information about some ingredients of Razylan
If you have been told by your doctor that you have an intolerance to lactose, a type of sugar, contact your doctor before taking
this medicinal product.

3. HOW TO TAKE RAZYLAN
Always take this product exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The dose is one tablet a day. It does not matter what time of day you take your tablet but taking the tablet at the same time
each day will help you remember to take it. You may take it with or without food.
The tablets are for oral use.
Swallow the tablet whole. If you wish you may take a glass of water with it.

Your doctor will tell you how long you should continue to take Razylan. The doctor may also advise you to take calcium and
vitamin D supplements.
If you stop taking Razylan
You should talk to your doctor first.
If you have the impression that the effect of this product is too strong or too weak, talk to your doctor or pharmacist.
If you forget to take Razylan
Take a tablet as soon as you remember and then continue as before.
If you take more Razylan than you should
Tell your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Razylan can cause side effects although not everybody gets them. The majority of side effects seen with
raloxifene have been mild.
All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you
get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting the
whole body).
If you experience any of the following serious side effects, contact your doctor immediately or go to the nearest hospital
accident and emergency department:
Uncommon side effects (affects 1 to 10 users in 1,000):
• Swelling, warmth, redness and pain in the legs, these are signs and symptoms associated with blood clots in the legs
(deep vein thrombosis)
• Chest pain and shortness of breath, these are signs and symptoms associated with blood clots in the lungs
(pulmonary embolism)
• Blurring, loss of vision or patchiness of images, these are signs and symptoms associated with blood clots in the eye
(retinal vein thrombosis)
Very rare side effects (affects less than 1 user in 10,000):
• Pain, whitening of the limbs, weakness, loss of sensation or paralysis, these are signs and symptoms of blood clots in an
artery (for example stroke)
The following side effects have also been reported:
Very common side effects (affects more than 1 user in 10):
• Hot flushes (vasodilation)
• Flu syndrome
Common side effects (affects 1 to 10 users in 100):
• Leg cramps
• Swelling of hands, feet and legs (peripheral oedema)
• Gallstones
Uncommon side effects (affects 1 to 10 users in 1,000):
• Skin around the vein is red and painful (superficial vein thrombophlebitis)
Very rare side effects (affects less than 1 user in 10,000):
• Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset
• Increased blood pressure
• Decrease in the number of the platelets in the blood
• Headache including migraine
• Mild breast symptoms such as pain, enlargement and tenderness
In rare cases, blood levels of liver enzymes may increase during treatment with Razylan.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE RAZYLAN
Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the pack.
Keep the blister in the outer carton in order to protect from light and moisture. Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no
longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Razylan contains
• The active substance is raloxifene hydrochloride. Each tablet contains 60 mg of raloxifene hydrochloride, which is equivalent
to 56mg raloxifene.
• The other ingredients of Razylan tablets are:
Tablet core: Sodium starch glycolate, citric acid monohydrate, microcrystalline cellulose, dibasic calcium phosphate,
poloxamer 407, magnesium stearate
Tablet coating: Hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide (E171) and macrogol/PEG 400.
What Razylan looks like and contents of the pack
Razylan are white elliptical, film coated tablets. They are packed in blisters. The blister boxes contain 14, 28, 30, 84, or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pharmathen S.A. 6, Dervenakion Str, 153 51, Pallini, Attiki, Greece
Manufacturer
Pharmathen SA, 6 Dervenakion Str, 153 51, Pallini Attiki, Greece
or
Pharmathen International SA, Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece
Distributor:
Aspire Pharma Limited, Bellamy House, Winton Road, Petersfield, Hampshire, GU32 3HA, United Kingdom
This leaflet was last approved on:
10/2013
1010070-P3.1

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

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

Hide
(web4)