Salagen
(Pilocarpine Hydrochloride)

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.

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. 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. 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.

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.

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.