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SALAGEN 5 MG FILM-COATED TABLETS

Active substance: PILOCARPINE HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

SALAGEN®
5 mg film-coated tablets
Pilocarpine hydrochloride

In this leaflet:
1. What Salagen is and what it is used for
2. Before you take Salagen
3. How to take Salagen
4. Possible side effects
5. How to store Salagen
6. Further information
1. What Salagen is and what it is used for
Salagen contains the active substance
pilocarpine hydrochloride, which belongs to a
group of medicines called
parasympathomimetic agents or cholinergic
agents.
Salagen stimulates certain nerves and glands
in your body. After you take Salagen, your body
will produce more saliva, tears, sweat, gastric
juices and mucus.
Salagen is used
• if you have been given radiotherapy for
cancer of the head or neck, and your mouth
feels very dry
• if you have been diagnosed with a condition
called Sjögren’s syndrome, and your mouth
and/or your eyes are dry and/or itchy

Eye tests
Your doctor may want to check your eyes
before you start the therapy. If you have not
had your eyes checked recently, tell your
doctor.
Excessive sweating
If you sweat excessively during Salagen
treatment, drink more liquids. If this does not
help, contact your doctor as you may suffer
from dehydration and organ damage if this
continues.

Read Direction
(8888)

Read all of this leaflet carefully before you
start taking 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.

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.
It is especially important to tell your doctor if
you are taking any medicines to treat:
• high blood pressure, heart problems or eye
problems (e.g. a beta blocker)
• diarrhoea (e.g. atropine)
• asthma (e.g. ipratropium inhaler)
Pregnancy
Do not use Salagen during pregnancy unless
your doctor recommends it.
If you are, or think you may be pregnant, tell
your doctor before taking Salagen.
Breast-feeding
Do not use Salagen if you are breast-feeding.
Ask your doctor for advice before taking any
medicine.
Male Fertility
If you are planning to father a child, ask your
doctor for advice before taking this medicine.
Driving and using machines

If you have any questions about how Salagen
works or why this medicine has been
prescribed for you, ask your doctor.

Salagen may cause dizziness or affect your
vision, in particular, you may have problems
seeing well at night. If this happens to you, do
not drive or use any tools or machines.

2. Before you take Salagen

3. How to take Salagen

Do not take Salagen

Always take Salagen exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.

Read Direction
(8888)

• if you are allergic (hypersensitive) to
pilocarpine hydrochloride or to any of the
other ingredients of Salagen
• if you have untreated asthma
• if you have untreated heart or kidney
disease
• if you have a chronic disease that is being
treated with a medicinal product that acts
like Salagen
• if you have an inflammation of the iris of the
eye (iritis)
If any of these apply to you, tell your doctor
before taking Salagen.
Take special care with Salagen
Tell your doctor before you take Salagen if you
have any:
• lung problems (e.g. asthma, chronic
bronchitis and/or chronic obstructive
pulmonary disease)
• heart problems (e.g. heart failure, irregular
pulse)
• gallbladder problems (e.g. gallstones)
• stomach problems (e.g. ulcers)
• liver problems (e.g. impaired liver function)
• nervous system problems/ mental problems
• kidney problems (e.g. renal insufficiency or
kidney stones)
• eye problems (e.g. narrow-angle glaucoma)

Salagen should only be taken by mouth. Do not
chew or bite the tablets.
Take Salagen tablets with a glass of water
during, or directly after, meals.
Try to take your tablets at intervals spread out
evenly over the day, e.g. take your first tablet
in the morning, one in the afternoon and one in
the evening.
Older people (65 years of age and over)
There are no special dose recommendations
for patients 65 years of age or older.
Children and adolescents
(2 to 17 years of age)
The safety of Salagen has not been established
in children or adolescents.

Proof 2
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16/12/2014 16:13

The Maltings

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Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

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The usual dose is:
• For patients who have been treated with
radiotherapy for head and neck cancer:
The recommended dose for adults is
one 5 mg tablet three times a day.
Make sure you take your last tablet of the
day with your evening meal.
• For patients who have been diagnosed
with Sjögren’s syndrome:
The recommended dose for adults is
one 5 mg tablet four times a day.
Make sure that you take your last tablet of
the day just before you go to bed.
• For patients with impaired liver function:
If you have cirrhosis (liver disorder), your
doctor will start your treatment at a lower
daily dose. Depending on how you respond
to treatment, your doctor may gradually
increase your dose up to the recommended
daily dose.
Depending on how you respond to treatment,
your doctor may suggest a higher or lower
dose. The dose can be increased up to 30 mg
(6 tablets) a day.
Your doctor will tell you exactly how long you
will need to take the tablets. If no improvement
is noted after 2-3 months your doctor may
decide to discontinue therapy.
If you take more Salagen than you should
If you have accidentally taken too many
Salagen tablets, talk to a doctor immediately.
You may require medical attention.
If you forget to take Salagen
If you are less than 6 hours late taking your
tablet, take it with food as soon as you
remember. Then delay taking your next tablet
until at least 3 to 4 hours after the usual time.
If you are over 6 hours late taking your tablet
and your next Salagen tablet is due, take only
one tablet. This means that you will have taken
one tablet less than usual that day.
Do not take a double dose to make up for a
forgotten tablet.
If you stop taking Salagen
Stopping treatment with Salagen may cause
your symptoms to get worse. Do not stop taking
your medicine unless your doctor tells you to.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Salagen can cause side
effects, although not everybody gets them.
Very common side effects
(affecting more than 1 in every 10 patients):
• flu-like symptoms
• sweating
• headache
• the need to pass urine more frequently
Common side effects
(affecting between 1 and 10 in
every 100 patients):
• fatigue
• chills
• runny nose
• allergic reactions including rash and itching
• dizziness
• diarrhoea; constipation
• indigestion; abdominal pain; nausea;
vomiting
• watering of the mouth
• flushing; rise in blood pressure
• palpitations (fast heart beats)
• watery eyes; abnormal vision; red, swollen
and painful eyes

Other side effects of the active substance
pilocarpine hydrochloride:
• breathing difficulties
• severe stomach or abdominal pain
• changes in the rhythm or rate of heart beat
• low blood pressure; fainting
• tremor
• changes in mental state including memory
disorders, mood swings and confusion
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.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via the
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
information on the safety of this medicine.
5. How to store Salagen
Keep out of the reach and sight of children.
Do not use Salagen after the expiry date which
is stated on the carton after EXP. The expiry
date refers to the last day of that month.
Do not store above 25˚C.
Store in the original package and container in
order to protect from light and humidity.
Do not use Salagen if you notice that the pack
is damaged or shows signs of tampering.
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 Salagen contains
– The active substance is pilocarpine
hydrochloride. Each Salagen 5 mg
film-coated tablet contains 5 mg of
pilocarpine hydrochloride.
– The other ingredients are cellulose
microcrystalline and stearic acid. The
coating is composed of Opadry white
OY-7300 (containing hypromellose,
macrogol 400 and titanium dioxide [E171])
and carnauba wax.
What Salagen looks like and contents of
the pack
Salagen tablets for oral use are white, round
biconvex tablets, marked “SAL” on one side
and “5 mg” on the other side.
The tablets are packed in blisters and supplied
in cartons containing 14, 21, 28 or 84 tablets.
Not all pack sizes may be available in your
country.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Novartis Pharmaceuticals UK Ltd
Frimley
Surrey
GU16 7SR
UK
Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nürnberg
Germany
This leaflet was last approved in
December 2014.

Uncommon side effects
(affecting between 1 and 10 in every
1,000 patients):
• more frequent urge to pass urine
• flatulence (wind)

GB 1330486_GB_LFT

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The Maltings

Approval Box and Ready for Print Box only to be used
in case ArtBase is not used.

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
/
No
WO:
1330486
Comp. Description: LFT_SALAGEN_FCT_5MG_GB
Comp. Number New: 1330486_GB
Comp. Number Old: N/A
Format/Dimension: 140 x 352mm
Tech. Drawing No.: 352x140_1020-e_rev1

/

Both

Production Site:
CTM:
Printing Colours:

Checking against manuscript according to
SOP-0022667. To be signed by AwOps.

Piramal Healthcare
Wood, Heather
Black

Technical Colours: Dimensions
Cutting

Technical approval. To be signed by Manufacturing Site.

Minimum Font Size: 9.5pt
Font Type: News Gothic
Proof Number: 2
Braille:

16/12/2014

Roy Shepherdson

! PLEASE TURN OVERPRINTING ON !
581722_0

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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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