Prospect: information for the user

Salagen 5 mg film-coated tablets

hydrochloride of pilocarpine

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you and should not be given to other people even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What Salagen is and for what it is used

2. What you need to know before starting to take Salagen

3. How to take Salagen

4. Possible adverse effects

5. Storage of Salagen

6. Contents of the package and additional information

Salagen contains the active ingredient hydrochloride of pilocarpine, which belongs to a group of medications called cholinergic or parasymptomatic agents.

Salagen stimulates certain nerves and glands in your body. After taking Salagen, your body will produce more saliva, tears, sweat, gastric juices, and mucous secretions.

Salagen is used

-when you have received radiation therapy for head or neck cancer, and you experience a very dry mouth

-when you have been diagnosed with a condition known as Sjögren's syndrome, and you experience dryness in your eyes and/or mouth

If you have any doubts about how Salagen works or why you have been prescribed this medication, ask your doctor.

Do not take Salagen

• If you are allergic to hydrochloride pilocarpine or any of the other components of this medication (listed in section 6)
• If you have uncontrolled asthma
• If you have uncontrolled heart or kidney disease
• If you have a chronic disease that may worsen due to treatment with a medication that acts like Salagen.Consult your doctor if you have doubts.
• If you have any disorder that should avoid constriction of the pupil of the eye (for example, acute inflammation of the iris of the eye), if you have inflammation of the iris of the eye (iritis)

If any of the above cases affect you, inform your doctor before taking Salagen.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Salagen.

Inform your doctor before taking Salagen if you have any of the following situations:

• Lung problems (for example, asthma, chronic bronchitis and/or chronic obstructive pulmonary disease)
• Severe heart problems (for example, heart failure, irregular heartbeat)
• Bile duct problems or gallstones
• Stomach or intestinal problems (for example, ulcers)
• Cognitive problems (learning difficulties, memory, perception, and problem-solving) or mental problems
• Kidney problems (for example, renal insufficiency or kidney stones)
• Eye problems (for example, narrow-angle glaucoma)

Excessive sweating

If you sweat excessively during treatment with Salagen, drink more liquids. If you are unable to drink enough liquids, consult your doctor as you may suffer dehydration and damage to an organ.

Children and adolescents

This medication should not be administered to children or adolescents under 18 years old.

Other medications and Salagen

Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication.

It is especially important to inform your doctor if you are using any of the following medications:

• Beta-blockers (medications used to treat high blood pressure, heart problems, or eye problems)
• Medications for diarrhea (for example, atropine)
• Medications for asthma (for example, ipratropium inhalers)
• Medications that activate the so-called parasympathetic nervous system (for example, some medications for glaucoma, the nervous system, or mental diseases, Alzheimer's disease, or medications used to accelerate intestinal transit)
• Medications that are metabolized by a liver enzyme called CYP2A6, for example, the medication to lower blood pressure irbesartan or medications to prevent blood coagulation (warfarin, dicumarol)

If you are unsure if any of your medications belong to this list, ask your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before taking this medication.

Pregnancy

Do not useSalagen during pregnancy unless your doctor recommends it.

If you are of childbearing age, use an effective contraceptive to prevent pregnancy while taking this medication. Ask your doctor for advice.

Breastfeeding

The excretion of pilocarpine in human milk is unknown. Your doctor will tell you if you should interrupt treatment with Salagen or interrupt breastfeeding.

Fertility

This medication may harm fertility in men and women. If you intend to have a child, consult your doctor before using this medication.

Driving and operating machines

Salagen may cause dizziness or affect your vision, especially at night. If this happens, do not drive vehicles or operate tools or machines.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again..

The recommended dose is:

• In patients who have been treated with radiation therapy for head and neck cancer:

The initial recommended dose in adults is a 5 mg tablet taken three times a day.

Make sure to take your last tablet of the day with dinner.

-In patients diagnosed with Sjögren's syndrome:

The recommended dose in adults is a 5 mg tablet taken four times a day.

Make sure to take your last tablet of the day just before bedtime.

Your doctor may suggest a higher or lower dose based on how you respond to treatment. The dose can be increased up to 30 mg (6 tablets) per day.

• Patients with altered liver function::

If you have cirrhosis (liver disorder), your doctor will instruct you to start treatment with a lower daily dose. Based on how you respond to treatment, your doctor may gradually increase your dose to the recommended daily dose.

Administration method

Salagen should only be taken orally.

Take Salagen tablets with a glass of water during meals or immediately after.

Try to take the tablets at regular intervals throughout the day, for example, take the first tablet in the morning, another in the afternoon, and another at night.

Treatment duration

Your doctor will tell you exactly how long you need to take the tablets. If you do not see any improvement after 2 or 3 months, your doctor may decide to discontinue treatment.

If you take more Salagen than you should:

If you accidentally take too many Salagen tablets,talk to a doctor immediately.You may require medical attention or urgent hospital admission.

The symptoms of overdose may include cramps, diarrhea, nausea, vomiting, involuntary passage of stool and urine, sweating, salivation, increased secretion of bronchi, pupil constriction, slow heart rate, low blood pressure, muscle spasms or contractions, generalized weakness.

If you forgot to take Salagen:

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Salagen:

Do not stop treatment unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Very common side effects(affect more than 1 in 10 people):

-flu-like symptoms

-sweating

-headache

-increased need to urinate

Common side effects(affect up to 1 in 10 people):

-weakness

-chills

-runny nose

-allergic reactions including rash and itching

-dizziness(more likely in patients over 65 years old)

-diarrhea; constipation

-indigestion; abdominal pain; nausea; vomiting

-increased salivation

-flushing; increased blood pressure

-palpitations (sensation of a faster, stronger or irregular heartbeat)

-tearful eyes; blurred visionor abnormal vision; red and swollen eyes(conjunctivitis), eye pain

Uncommon side effects(affect up to 1 in 100 people):

-sudden need to urinate

-flatulence (gas)

Other side effects of the active ingredient hydrochloride of pilocarpine:

-breathing difficulties

-stomach or abdominal spasms

-changes in heart rhythm, such as slow heart rate (bradycardia), rapid heart rate (tachycardia), irregular heartbeats (arrhythmia), alterations in heart conduction that prevent it from functioning normally (atrioventricular block),

• severe drop in blood pressure that can cause loss of consciousness (shock)

-low blood pressure

-tremor

-changes in mental state including memory disorders, hallucinations (seeing or hearing something that is not real), agitation, mood changes and confusion

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use (www.notificaRAM.es). By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Store in the original packaging and container to protect it from light and moisture.

Do not use this medication if you observe that the packaging is damaged or shows signs of having been manipulated.

Medications should not be disposed of through drains or in the trash.

Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.By doing so, you will help protect the environment.

Salagen Composition

-The active ingredient is hydrochloride of pilocarpine. Each Salagen 5 mg coated tablet contains 5 mg of hydrochloride of pilocarpine.

-The other components are microcrystalline cellulose and stearic acid. The coating consists of opadry white OY-7300 (which contains hypromellose, macrogol 400 and titanium dioxide (E-171)) and carnauba wax.

Appearance of the product and contents of the packaging

Salagen oral tablets are white, round, biconvex tablets, marked with "SAL" on one face and with "5" on the other.

The tablets are packaged in blisters and are presented in boxes containing 14, 21, 28 or 84 tablets. Some packaging sizes may only be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Merus Labs Luxco II S.à.R.L.

208, Val des Bons Malades

L-2121 Luxembourg

Luxembourg

Responsible manufacturer

Norgine BV,

Antonio Vivaldistraat 150,

1083 HP Amsterdam,

Netherlands

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2nd Floor

28046 Madrid

Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland)with the following names:

Germany, Austria, Spain, Finland, Italy, Netherlands, Portugal, United Kingdom (Northern Ireland), Sweden: SALAGEN

Last review date of this leaflet:07/2023

Detailed information about this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu , and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.