What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 44374/0002 .


Salagen 5 mg Film Coated Tablets

Package leaflet: Information for the user

Salagen® 5 mg film-coated tablets

Pilocarpine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Salagen is and what it is used for
2. What you need to know before you take Salagen
3. How to take Salagen
4. Possible side effects
5. How to store Salagen
6. Contents of the pack and other 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

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

2. What you need to know 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 (listed in section 6).
  • 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.

Warnings and precautions

Talk to your doctor or pharmacist 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 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.

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.

Other medicines and Salagen

Please tell your doctor or pharmacist if you are taking, have recently taken any other medicines or might take any other medicines.

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, breast-feeding and fertility

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

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

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

The recommended 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.

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.

Use in children and adolescents (2 to 17 years of age)

The safety of Salagen has not been established in children or adolescents.

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

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 Salagen

Keep this medicine out of the sight and reach 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

Norgine Pharmaceuticals Limited
Norgine House
Widewater Place
Moorhall Road
Harefield
Uxbridge
UB9 6NS
UK

Manufacturer

Norgine B. V.
Antonio Vivaldistraat 150
1083 HP Amsterdam
The Netherlands

This leaflet was last approved in December 2019