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Salagen 5mg Film-Coated Tablets

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Document: leaflet MAH BRAND_PLPI 15184-1487 change

Ref: 1487/270415/1/F

Salagen 5mg film-coated tablets

(pilocarpine hydrochloride)

Patient Information 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.

Your medicine is called Salagen 5mg film-coated tablets but will be referred to as Salagen throughout this leaflet.

In this leaflet:

What Salagen is and what it is used for [a Before you take Salagen [a How to take Salagen ^ Possible side effects [m How to store Salagen Further information

^ 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 Sjogren'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.

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)

Eve 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.

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.

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 Sjogren'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.

Salagen 5mg film-coated tablets

(pilocarpine hydrochloride)

Patient Information Leaflet (continued)

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, pharmacist or nurse. 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 SIGHT AND REACH OF CHILDREN.

*    Do not store above 25°C.

*    Store in the original container in order to protect from light and moisture.

*    Do not take Salagen after the expiry date shown on the carton and blister label. If your doctor tells you to stop taking this medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

*    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

*    If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do.

Further information

What Salagen contains:

Each film-coated tablet contains 5mg of pilocarpine hydrochloride.

The other ingredients are cellulose microcrystalline and stearic acid.

What Salagen looks like and contents of the pack

Salagen is a white, round, biconvex tablet, marked SAL on one side and 5 on the reverse side.

Each blister pack contains 84 film-coated tablets.

Manufacturer and Licence Holder

This medicine is manufactured by Piramal Healthcare UK limited, UK and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

|PQM| PL 15184/1487 Salagen 5mg film-coated tablets Revision date: 27/04/15

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