Salagen

Package Leaflet: Information for the User

Salagen

5 mg film-coated tablets
Pilocarpine hydrochloride
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Salagen is and what it is used for
2. What you need to know before taking 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 pilocarpine hydrochloride as the active substance, which belongs to a group of
medicines called parasympathomimetic or cholinergic agents.
Salagen stimulates certain nerves and glands in your body. After taking Salagen, your body will
produce more saliva, tears, sweat, gastric juices, and mucus.
Salagen is used

• If you have been treated with radiotherapy for cancer of the head or neck and experience a very dry mouth,
• If you have been diagnosed with a disease called Sjögren's syndrome and your mouth and/or eyes are dry and itchy.

If you have any doubts about how Salagen works or why it has been prescribed for you,
please ask your doctor.

2. What you need to know before taking Salagen

Do not take Salagen

• If you are allergic (hypersensitive) to pilocarpine hydrochloride or to any of the excipients of Salagen (listed in section 6).
• If you have untreated asthma.
• If you have untreated heart or kidney diseases.
• If you have chronic conditions treated with medicines that work similarly to Salagen.
• If you have inflammation of the iris of the eye (iritis).

If you are in any of these conditions, contact your doctor before taking Salagen.

Warnings and precautions
Talk to your doctor or pharmacist before taking Salagen.
Contact your doctor before taking Salagen if you have:

• lung problems (e.g. asthma, chronic bronchitis, and/or chronic obstructive pulmonary disease).
• Heart problems (e.g. heart failure, irregular heartbeat).
• Gallbladder problems (e.g. gallstones).
• Stomach problems (e.g. ulcers).
• Liver problems (e.g. impaired liver function).
• Nervous system/mental health problems.
• Kidney problems (e.g. kidney failure or kidney stones).
• Eye problems (e.g. closed-angle glaucoma).

Eye examination
Your doctor may want to examine your eyes before starting treatment. If you have not recently had your eyes checked, inform your doctor.

Excessive sweating
If you sweat excessively during treatment with Salagen, drink more fluids. If this does not help, contact your doctor, because if the condition persists, you may suffer from dehydration and organ damage.

Other medicines and Salagen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, it is important that you inform your doctor if you are taking any medicines for:

• high blood pressure, heart problems, or eye problems (e.g. a beta-blocker).
• Diarrhea (e.g. atropine).
• Asthma (e.g. ipratropium inhalations).

Pregnancy, breastfeeding and fertility
Pregnancy
Do not take Salagen during pregnancy unless your doctor has recommended it. If you are pregnant or think you might be, inform your doctor before taking Salagen.

Breastfeeding
Do not take Salagen if you are breastfeeding.
Ask your doctor for advice before taking any medicine.

Male fertility
If you and your partner are planning to conceive a child, ask your doctor for advice before taking this medicine.

Driving and using machines
Salagen may cause dizziness or affect your vision, particularly you may have difficulty seeing clearly at night. If this occurs, do not drive and do not operate tools or machinery.

3. How to take Salagen

Always take Salagen exactly as instructed by your doctor. If you have any doubts, you must consult your doctor or pharmacist.
The recommended dose is:

• For patients who have been treated with radiotherapy for head or neck cancer: The recommended dose for adults is one 5 mg tablet three times daily. Make sure to take the last tablet of the day with your evening meal.
• For patients diagnosed with Sjögren's syndrome: The recommended dose for adults is one 5 mg tablet four times daily. Make sure to take the last tablet of the day just before going to bed.
• For patients with impaired liver function: If you have cirrhosis (liver disease), your doctor will start your treatment with a lower daily dose. Depending on your response to treatment, your doctor may gradually increase your dose up to the recommended daily dose.

Depending on your response to treatment, your doctor may suggest a higher or lower dose.
The dose may be increased up to 30 mg (6 tablets) per day.
Your doctor will tell you exactly how long you should take the tablets. If no improvement is seen after 2 or 3 months, your doctor may decide to discontinue therapy.
Salagen should be taken by mouth. Do not chew or bite the tablets. Take Salagen tablets with a glass of water, during or immediately after meals.
Try to take the tablets at regular intervals throughout the day; for example, take one tablet in the morning, one in the afternoon, and one in the evening.

Elderly patients (65 years of age and older)
There are no special dosage recommendations for patients aged 65 years and older.

Use in children and adolescents (from 2 to 17 years of age)
The safety of Salagen has not been established in children and adolescents.

If you take more Salagen than you should
If you accidentally take too many Salagen tablets, contact your doctor immediately.
You may require medical treatment.

If you forget to take Salagen
If less than 6 hours have passed since you took your last tablet, take it with food as soon as you remember. Then delay taking the next tablet by at least 3 or 4 hours from your usual time.
If more than 6 hours have passed since you took your last tablet and it is time for your next dose, take only one tablet. This means you will have taken one tablet less than your usual daily dose. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Salagen
Stopping treatment with Salagen may cause a worsening of symptoms. Do not stop treatment unless your doctor tells you to do so.
If you have any doubts about how to use Salagen, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Salagen can cause side effects, although not everyone experiences them.

Very common side effects (occurring in more than 1 in 10 patients):

• Flu-like symptoms
• Sweating
• Headache
• Need to urinate more frequently

Common side effects (occurring in 1 to 10 in 100 patients):

• Fatigue
• Chills
• Runny nose
• Allergic reactions including rash and itching
• Dizziness
• Diarrhea; constipation
• Indigestion; abdominal pain; nausea; vomiting
• Increased salivation
• Flushing (increased blood pressure)
• Palpitations (increased heart rate)
• Watery eyes; blurred vision; red, swollen and painful eyes

Uncommon side effects (occurring in 1 to 10 in 1,000 patients):

• Urgent need to urinate
• Flatulence

Other side effects associated with the active substance pilocarpine hydrochloride:

• Difficulty breathing
• Severe stomach or abdominal pain
• Changes in heart rhythm and heart rate
• Low blood pressure; fainting
• Tremors
• Changes in mental state including memory disturbances, mood swings and confusion

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. 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 stated on the packaging after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep in the original packaging and outer box to protect the medicine from light and moisture.
Do not use Salagen if you notice that the packaging is damaged or shows any signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Salagen contains

• The active substance is pilocarpine hydrochloride. Each 5 mg Salagen film-coated tablet contains 5 mg of pilocarpine hydrochloride.
• The excipients are microcrystalline cellulose and stearic acid. The coating consists of Opadry White, OY-7300 (containing hypromellose, polyethylene glycol 400, titanium dioxide [E171]) and carnauba wax.

Description of the appearance of Salagen and package contents
Salagen oral tablets are white, round, biconvex tablets, marked with “SAL” on one side and “5” on the other.
The tablets are packaged in blisters supplied in boxes containing 14, 21, 28 or 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Merus Labs Luxco II S.à R.L.
26-28, rue Edward Steichen,
L-2540, Luxembourg

Manufacturing site (batch release):
Merus Labs Netherlands B.V.
Alexander Battalaan 37
Maastricht, 6221 CB
The Netherlands