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STRIANT SR 30MG MUCOADHESIVE BUCCAL TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

30 mg Mucoadhesive Buccal Tablets
Testosterone
Read all of this leaflet carefully before you start using
this medicine
• Keep this leaflet. You may need 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 Striant®SR is and what it is used for
2. Before you use Striant®SR
3. How to use Striant®SR
4. Possible side effects
5. How to store Striant®SR
6. Further information
1. WHAT STRIANT®SR IS AND WHAT IT IS USED FOR
Striant®SR contains testosterone, a naturally occurring male sex
hormone produced by the testes. Testosterone is important in the
growth and development of the penis and testicles, the growth of
body hair, bones and muscles, and the development of vocal
chords which causes the voice to deepen.
Striant®SR is used to treat adult males who produce low levels of
testosterone (hypogonadism). Striant®SR is a replacement therapy
which is used to replace testosterone levels in the body.
2. BEFORE YOU USE STRIANT SR

Using Striant®SR with 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.
In particular, please tell your doctor if you are taking:
• medicines that affect blood clotting (anticoagulants) such as
warfarin
• steroidal hormones such as ACTH or corticosteroids
Using Striant®SR with food and drink
Striant®SR can be used before consuming food or drink (refer to
Section 3 for further instructions).
Athletes
Striant®SR contains testosterone which may produce a positive
reaction in anti-doping tests.
Pregnancy and breast-feeding
Do not use Striant®SR if you are a woman. It has not been tested
in women and if you are pregnant, it may harm an unborn baby.
Do not breast-feed if you have used Striant®SR by mistake.
Driving and using machines
Striant®SR should not affect your ability to drive and use
machinery. If you do experience any serious side effects, do not
drive and contact your doctor or pharmacist.
Important information about some of the ingredients of
Striant®SR
Striant®SR contains lactose. If you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor
before using this medicinal product.
3. HOW TO USE STRIANT®SR
Always use Striant®SR exactly as your doctor has told you. Check
with your doctor or pharmacist if you are unsure of any of the
instructions.
The normal dose is two tablets a day, one in the morning and one
in the evening, about 12 hours apart and after brushing your teeth.

®

Do not use Striant®SR
• if you are allergic (hypersensitive) to testosterone or any
of the other ingredients. (See Section 6: Further
information.)
• if you have or have had breast cancer
• if you have or have had prostate cancer
• if you have or have had a liver tumour
• if you have a kidney disorder called nephrotic syndrome
• if you have high levels of calcium in your blood or urine
• if you are female.
• if you are under 18 years of age
Take special care with Striant®SR
Before you use Striant®SR, please tell your doctor or pharmacist:
• if you have bone cancer
• if you have any heart problems
• if you have any other kidney disease
• if you have any liver disease
• if you have high blood pressure (hypertension)
• if you have migraines
• if you suffer from fits (epilepsy)
• if you suffer from water retention
• if you are a diabetic
• if you suffer from dry mouth
• if you are overweight
• if you have lung disease which causes breathing difficulties
• if you are over 65 years of age.
While you are taking Striant®SR, you should expect to have regular
blood tests and checks of your prostate gland and breast.

To insert Striant®SR
1. Push one tablet out of the blister, lift your lip and place the
curved side of the tablet directly onto the upper gum. The tablet
should be placed above the incisor
(eye tooth) on the left or right side
of the mouth in a position you find
most comfortable.
2. Carefully allow your lip to go
back into position. Place your finger
on your skin over the tablet. Press
the tablet onto the gum for 30
seconds. This will help the tablet to
stick to your gum.
3. The tablet should stick to your gum after 30 seconds and stay
in position until removed.
4. Try not to dislodge the tablet with your tongue during the first
5 minutes.
5. As the tablet absorbs moisture from your mouth it will begin to
soften, forming a gel which will mould to the shape of your gum.
The tablet will not dissolve completely.
6. Remove the residual gel of the tablet from the previous dose
before applying the next dose.
7. Apply the next dose to the alternate side of the mouth.
Do not chew or swallow the tablet as it will not be effective. If you
accidently swallow a tablet, it will not harm you.

To remove Striant®SR
1. Gently slide the remaining gel from the tablet downwards
from the gum towards the tooth to avoid scratching the gum.

• low sperm count causing a decrease in testicle size
• prostate cancer (although it is unclear if testosterone can cause
prostate cancer)

2. Dispose of used tablets carefully so that children and animals
do not accidentally swallow them. (See Section 5: How to store
Striant®SR.)

5. HOW TO STORE STRIANT®SR
Keep out of the reach and sight of children.

If Striant SR fails to stick or a tablet is dislodged
• If the tablet does not stick or falls off during the 12 hour
period, the old tablet should be removed and a new one
applied.
• If the tablet falls out of position four hours or less before the
next dose, replace the tablet with a new tablet. This should be
regarded as the second dose for the 24 hour period and can be
left in place for up to 16 hours until your next dose is due.

Do not use Striant®SR after the expiry date which is stated on the
blister pack and carton. The expiry date refers to the last day of
that month.

If you use more Striant®SR than you should
Only use Striant®SR as instructed by your doctor. If an additional
tablet is stuck on by mistake, remove the extra tablet and throw it
away carefully. (See Section 5: How to store Striant®SR.) Do not
re-use the tablets. Use the next dose at the usual time.

Striant®SR should be stored in the original package in order to
protect from moisture and light.

®

If you forget to use Striant®SR
If you forget to use a tablet, apply a new tablet as soon as possible.
Do not use a double dose to make up for a forgotten tablet.
If you have any further questions on the use of Striant®SR, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Striant®SR can cause side effects although not
everybody gets them.
If you experience any of the following side-effects during
treatment, stop using Striant®SR and tell your doctor
immediately:
• swelling of the face, lips or tongue, skin rash, itching or
redness of the skin
• tiredness, confusion, swollen feet or hands, muscle weakness
• difficulties breathing at night
• the urge to pass urine more frequently, difficulties or
discomfort passing urine or blood present in the urine or semen
If any of the side effects listed below gets serious, or if you notice
any side effects not listed in the leaflet, please tell your doctor or
pharmacist.
Common (affects 1 to 10 users in 100):
• irritation, pain or swelling of the gum where the tablet has
been applied
• changes in taste
• inflammation of the gums
• headache
• tiredness
• increased red blood cell count
• increase in proteins produced by the prostate gland
Other side effects caused by testosterone include:
• weight gain
• water retention and swelling (especially of the ankles)
• problems passing water
• muscle cramps
• nervousness or changes in mood
• hostility
• depression
• yellowing of the skin or whites of the eyes (jaundice) in very
rare cases
• abnormal liver function tests in very rare cases
• hair loss
• acne or oily skin
• changes in sex drive (libido)
• frequent or long lasting erections
• painful persistent erections

Do not use if you notice a slight yellowing of the tablets and/or
the blisters. Poor adhesion of the tablets indicates deterioration of
the product. If this happens it should not be used and should be
returned to the pharmacist.

Disposal
When Striant®SR is removed from the mouth it should be disposed
of safely in a way that prevents children or pets accidentally
applying or taking the used tablet.
Unused 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 Striant®SR contains
The active substance is testosterone. Each tablet contains 30 mg
testosterone.
The other ingredients are: magnesium stearate, colloidal
anhydrous silica, talc, hypromellose, polycarbophil, carbomer
974P, maize starch, lactose anhydrous and lactose monohydrate.
What Striant®SR looks like and the contents of the pack
Striant®SR tablets are white to off white in colour, slim and circular
shaped. One side of the tablet is convex (curved outwards) and
the flat side is debossed with the letter A or C.
The tablets are individually sealed in sheets of blisters. There are 10
tablets per sheet and 30 or 60 tablets in a carton.
Not all pack sizes may be marketed.
Market Authorisation Holder and Manufacturer:

Market Authorisation Holder
The Urology Company Ltd.,
1st Floor, St Andrew’s House,
18-20 St Andrew Street, London,
United Kingdom, EC4A 3AG.
Manufacturer
Mipharm S.p.A.
Via B. Quaranta, 12-20141,
Milan, Italy.
Distributor
The Urology Company Ltd.,
1st Floor, St Andrew’s House,
18-20 St Andrew Street, London,
United Kingdom, EC4A 3AG.
This leaflet was last approved in 09/2012

Expand Transcript

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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