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PILOCARPINE HYDROCHLORIDE 5 MG FILM-COATED TABLETS

Active substance(s): PILOCARPINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SALAGEN®
5 mg film-coated tablets
(pilocarpine hydrochloride)
This medicine is available as the above name, but will be
referred to as Salagen throughout the following leaflet.
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.
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.

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.
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.

Salagen is used

Male Fertility

• 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

If you are planning to father a child, ask your doctor for advice
before taking this medicine.

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

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.
3. How to take Salagen

2. Before you take Salagen
Do not take Salagen
• 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)

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

• 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: 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 sight and reach of children.

If you forget to take Salagen

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 in order to protect from light and
moisture.
Do not use Salagen if you notice that the pack is damaged or
shows signs of tampering.

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.

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.
If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your
pharmacist who will advise you what to do.

If you stop taking Salagen

6. Further information

Stopping treatment with Salagen may cause your symptoms
to get worse. Do not stop taking your medicine unless your
doctor tells you to.

What Salagen contains

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

– The active substance is pilocarpine hydrochloride. Each
film-coated tablet contains 5 mg of pilocarpine
hydrochloride.
– The other ingredients are microcrystalline cellulose and
stearic acid.
What Salagen looks like and contents of the pack
Salagen tablets for oral use are white, round, biconvex, filmcoated tablets, marked “SAL” on one side and “5” on the other
side.
The tablets are packed in blisters and supplied in cartons
containing 84 tablets.
PL: 15814/1258

POM

Manufactured by Piramal Healthcare UK limited, UK.
Procured from within the EU and repackaged by the
Product Licence holder:
O.P.D. Laboratories Ltd., Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 07.07.2016.
Salagen is a registered trademark of Eisai Inc., USA.
To request a copy of this leaflet in Braille, large print or audio
please call 01923 332 796.

PACKAGE LEAFLET: INFORMATION FOR THE USER

PILOCARPINE HYDROCHLORIDE
5 mg film-coated tablets
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.









In this leaflet:
1. What Pilocarpine Hydrochloride 5 mg film-coated tablets
are and what they are used for
2. Before you take Pilocarpine Hydrochloride 5 mg film-coated
tablets
3. How to take Pilocarpine Hydrochloride 5 mg film-coated
tablets
4. Possible side effects
5. How to store Pilocarpine Hydrochloride 5 mg film-coated
tablets
6. Further information

Excessive sweating
If you sweat excessively during Pilocarpine Hydrochloride 5 mg
film-coated tablets treatment, drink more liquids. If this does not
help, contact your doctor as you may suffer from dehydration
and organ damage if this continues.

1. What Pilocarpine Hydrochloride 5 mg film-coated
tablets are and what they are used for
Pilocarpine Hydrochloride 5 mg film-coated tablets contain the
active substance pilocarpine hydrochloride, which belongs to
a group of medicines called parasympathomimetic agents or
cholinergic agents.
Pilocarpine Hydrochloride 5 mg film-coated tablets stimulate
certain nerves and glands in your body. After you take
Pilocarpine Hydrochloride 5 mg film-coated tablets, your body
will produce more saliva, tears, sweat, gastric juices and mucus.
Pilocarpine Hydrochloride 5 mg film-coated tablets are
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
If you have any questions about how Pilocarpine
Hydrochloride 5 mg film-coated tablets work or why this
medicine has been prescribed for you, ask your doctor.

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)

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.

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 Pilocarpine Hydrochloride 5 mg film-coated tablets
during pregnancy unless your doctor recommends it.
If you are, or think you may be pregnant, tell your doctor before
taking Pilocarpine Hydrochloride 5 mg film-coated tablets.
Breast-feeding
Do not use Pilocarpine Hydrochloride 5 mg film-coated
tablets 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

2. Before you take Pilocarpine Hydrochloride 5 mg filmcoated tablets

Pilocarpine Hydrochloride 5 mg film-coated tablets 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.

Do not take Pilocarpine Hydrochloride 5 mg film-coated
tablets

3. How to take Pilocarpine Hydrochloride 5 mg filmcoated tablets

• if you are allergic (hypersensitive) to pilocarpine
hydrochloride or to any of the other ingredients of
Pilocarpine Hydrochloride 5 mg film-coated tablets
• 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 Pilocarpine Hydrochloride 5
mg film-coated tablets
• if you have an inflammation of the iris of the eye (iritis)

Always take Pilocarpine Hydrochloride 5 mg film-coated
tablets exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.

If any of these apply to you, tell your doctor before taking
Pilocarpine Hydrochloride 5 mg film-coated tablets.
Take special care with Pilocarpine Hydrochloride 5 mg
film-coated tablets
Tell your doctor before you take Pilocarpine Hydrochloride 5
mg film-coated tablets if you have any:
• lung problems (e.g. asthma, chronic bronchitis and/or
chronic obstructive pulmonary disease)

Pilocarpine Hydrochloride 5 mg film-coated tablets should
only be taken by mouth. Do not chew or bite the tablets.
Take Pilocarpine Hydrochloride 5 mg film-coated 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 Pilocarpine Hydrochloride 5 mg film-coated
tablets has not been established in children or adolescents.

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 Pilocarpine Hydrochloride 5 mg filmcoated tablets than you should
If you have accidentally taken too many Pilocarpine
Hydrochloride 5 mg film-coated tablets, talk to a doctor
immediately. You may require medical attention.
If you forget to take Pilocarpine Hydrochloride 5 mg filmcoated tablets
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 Pilocarpine
Hydrochloride 5 mg film-coated 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 Pilocarpine Hydrochloride 5 mg filmcoated tablets
Stopping treatment with Pilocarpine Hydrochloride 5 mg filmcoated tablets 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, Pilocarpine Hydrochloride 5 mg film-coated
tablets 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
Uncommon side effects (affecting between 1 and 10 in
every 1,000 patients):
• more frequent urge to pass urine
• flatulence (wind)
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: 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 Pilocarpine Hydrochloride 5 mg filmcoated tablets
Keep out of the sight and reach of children.
Do not use Pilocarpine Hydrochloride 5 mg film-coated tablets
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 in order to protect from light and
moisture.
Do not use Pilocarpine Hydrochloride 5 mg film-coated tablets
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.
If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your
pharmacist who will advise you what to do.
6. Further information
What Pilocarpine Hydrochloride 5 mg film-coated tablets
contain
– The active substance is pilocarpine hydrochloride. Each
film-coated tablet contains 5 mg of pilocarpine
hydrochloride.
– The other ingredients are microcrystalline cellulose and
stearic acid.
What Pilocarpine Hydrochloride 5 mg film-coated tablets
look like and content of the pack
Pilocarpine Hydrochloride 5 mg film-coated tablets for oral use
are white, round, biconvex, film-coated tablets, marked “SAL”
on one side and “5” on the other side.
The tablets are packed in blisters and supplied in cartons
containing 84 tablets.
PL: 15814/1258

POM

Manufactured by Piramal Healthcare UK limited, UK.
Procured from within the EU and repackaged by the
Product Licence holder:
O.P.D. Laboratories Ltd., Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 07.07.2016.
To request a copy of this leaflet in Braille, large print or audio
please call 01923 332 796.

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.

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