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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
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


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)
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.
Do not use Salagen if you are breast-feeding.
Ask your doctor for advice before taking any
Male Fertility
If you are planning to father a child, ask your
doctor for advice before taking this medicine.
Driving and using machines
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.


• 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
• 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.
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
• 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.


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

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

Take special care with Salagen

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




Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it
• 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



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.

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
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at:
By reporting side effects you can help provide
more information on the safety of this
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

If you forget to take Salagen

What Salagen contains

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.

–– 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.

If you stop taking Salagen

What Salagen looks like and contents of
the pack

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;
• watering of the mouth
• flushing; rise in blood pressure
• palpitations (fast heart beats)
• watery eyes; abnormal vision; red, swollen
and painful eyes
Uncommon side effects
(affecting between 1 and 10 in every
1,000 patients):
• more frequent urge to pass urine
• flatulence (wind)

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
Marketing Authorisation Holder and
Marketing Authorisation Holder
Merus Labs Luxco II S.à.R.L.
26-28, rue Edward Steichen
L-2540 Luxembourg
Merus Labs Netherlands B.V.
Alexander Battalaan 37
Maastricht, 6221 CB
The Netherlands
This leaflet was last approved in 05/2016

20715952 GB

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.