Salagen (Pilocarpine)

How does it work?

Salagen tablets contain the active ingredient pilocarpine, which is a type of medicine known as a cholinergic.

Pilocarpine works by mimicking the action of a neurotransmitter called acetylcholine.

Neurotransmitters are chemicals that are stored in nerve cells in the brain and nervous system. They are involved in transmitting messages between nerve cells. Acetylcholine is involved in transmitting nerve messages that control many of the processes that happen automatically in the body, ie without our voluntary control.

Acetylcholine causes the salivary glands to make saliva and the lacrimal glands in the eye to make tears to lubricate the eyes. By mimicking acetylcholine, pilocarpine stimulates the production of saliva and tears, which can help to relieve the symptoms of dry mouth and eyes.

It can take two to three months of treatment with this medicine before dry mouth or eye symptoms are improved. The medicine should be stopped if there is no improvement after this time.

What is it used for?

  • Relieving a dry mouth in people who have underactive salivary glands as a result of radiotherapy for cancer of the head or neck (xerostomia).
  • Relieving dry mouth and dry eyes in people who have been diagnosed with Sjogren's syndrome, which is an autoimmune disorder in which immune cells in the body attack the glands that produce tears and saliva.

How do I take it?

  • Salagen tablets should be swallowed whole with a full glass of water (at least 150ml) either with, or just after a meal. The tablets should not be not broken, chewed or crushed.
  • The dose prescribed will depend on the condition being treated. It is important to follow the instructions given by your doctor. These will be printed on the dispensing label your pharmacist has put on the packet of medicine. The usual dose for people who have had radiotherapy is one tablet three times a day, with the last dose being taken with the evening meal. For dry mouth and/or eyes due to Sjogren's syndrome the usual dose is one tablet four times a day, with the last tablet being taken just before bedtime.

Warning!

  • This medicine may cause dizziness or blurred vision and problems with depth perception, so may affect your ability to drive or operate machinery safely, particularly at night or in low light. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.
  • This medicine can make you sweat more than usual. To avoid getting dehydrated you should make sure that you drink plenty of fluids while taking this medicine.

Use with caution in

  • Asthma.
  • Decreased kidney function.
  • Liver cirrhosis.
  • People with heart disease such as high blood pressure, angina, heart failure, irregular heartbeats, or history of heart attack.
  • People with chronic bronchitis or chronic obstructive pulmonary disease (COPD).
  • People with gallstones (cholelithiasis) or any problems with the bile duct.
  • People with kidney stones.
  • People with a history of psychiatric disorders, eg depression.
  • Peptic ulcer.
  • Narrow angle glaucoma.
  • Men attempting to father a child (studies in animals have shown a potential effect of this medicine on sperm production).

Not to be used in

  • Uncontrolled asthma.
  • Uncontrolled chronic obstructive pulmonary disease (COPD).
  • Severely decreased kidney function that is causing problems with the heart.
  • People with acute inflammation of the iris (iritis).
  • The safety and efficacy of this medicine in children has not been established. It is not recommended for children.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

  • The safety of this medicine for use during pregnancy has not been established. It should not be used in pregnant women unless the potential benefits to the mother outweigh any risks to the developing baby. The medicine could theoretically stimulate the involuntary muscle in the womb. Seek further medical advice from your doctor.
  • It is not known if this medicine passes into breast milk. Mothers who need treatment with this medicine should not breastfeed. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)

  • Headache.
  • Increased need to pass urine (urinary frequency).
  • Increased sweating.
  • Flu-like symptoms.

Common (affect between 1 in 10 and 1 in 100 people)

  • Visual disturbances such as blurred vision, conjunctivitis, eye pain and watering eyes.
  • Dizziness.
  • High blood pressure.
  • Flushing.
  • Awareness of your heartbeat (palpitations).
  • Runny nose.
  • Disturbances of the gut such as indigestion, diarrhoea, abdominal pain, nausea, vomiting and constipation.
  • Increased saliva in the mouth.
  • Allergic reactions with rash and itching of skin.
  • Weakness or loss of strength (asthenia).
  • Chills.

Uncommon side effects (affect between 1 in 100 and 1 in 1000 people)

  • Flatulence (wind).
  • Sudden urgent need to pass urine (urinary urgency).

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while being treated with this one, to make sure that the combination is safe.

Salagen tablets should be used with caution in people who are taking beta-blockers such as atenolol, as the combination could affect the rhythm of the heart.

The effect of pilocarpine may be reduced in people having treatment with anticholinergic medicines such as the following; equally pilocarpine may oppose the effects of some of these:

  • anticholinergic medicines for urinary incontinence, eg tolterodine
  • anticholinergic medicines for Parkinson’s symptoms, eg procyclidine
  • atropine
  • hyoscine
  • ipratropium
  • MAOI antidepressants such as phenelzine
  • tricyclic antidepressants such as amitriptyline.

Other medicines containing the same active ingredient

There are currently no other oral medicines available in the UK that contain pilocarpine as the active ingredient.