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RAZYLAN 60MG FILM COATED TABLETS

Active substance(s): RALOXIFENE HYDROCHLORIDE

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If you stop taking Razylan
It is important that you continue taking Razylan for as long as your doctor prescribes the medicine.
Razylan can treat or prevent your osteoporosis only if you continue to take the tablets.
If you have any further questions on the use of this medicine ask your doctor or pharmacist.
If you forget to take Razylan
Take a tablet as soon as you remember and then continue as before. Do not take a double dose to make up for a forgotten dose.
If you take more Razylan than you should
Tell your doctor or pharmacist. If you take more Razylan than you should you could have leg cramps and dizziness.

4. P

raloxifene have been mild.
All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you
whole body).
accident and emergency department:
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)
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).
Very common

asodilation)
• Flu syndrome
• Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset
• Increased blood pressure
:
Common
• Headache including migraine
• Leg cramps
• Swelling of hands, feet and legs (peripheral oedema)
• Gallstones
• Rash
• Mild breast symptoms such as pain, enlargement and tenderness
Uncommon
• Sk
• Decrease in the number of platelets in the blood
In rare cases, blood levels of liver enzymes may increase during treatment with Razylan.

5. How to store Razylan

Keep out of the sight and reach of children.
Do not use after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Keep the blister in the outer carton in order to protect from light and moisture. Do not freeze.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Razylan contains
• The active substance is raloxifene hydrochloride. Each tablet contains 60mg 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
. They are packed in blisters. The blister boxes contain 14, 28, 30, 84, or 90 tablets.
Razylan are white elliptical,
Not all pack sizes may be marketed.
Marketing Authorisation Holder and 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
Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom
This leaflet was last revised on: 10/2016

P1010070-5.1

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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.

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