SALAGEN 5 mg Film-Coated Tablets

2. What you need to know before you take Salagen

Do not take Salagen

• if you are allergic to pilocarpine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if you have uncontrolled asthma
• if you have uncontrolled heart or kidney disease
• if you have a chronic condition that may worsen due to treatment with a medicine that acts like Salagen. Consult your doctor if you have doubts.
• if you have a disorder that requires you to avoid constriction of the pupil of the eye (e.g., 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 apply to you, inform your doctor before taking Salagen.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Salagen.

Tell your doctor before taking Salagen if you have any of the following conditions:

• lung problems (e.g., asthma, chronic bronchitis, and/or chronic obstructive pulmonary disease)
• severe heart problems (e.g., heart failure, irregular heartbeat)
• gallbladder or bile duct problems (e.g., gallstones in the bile ducts)
• stomach or intestinal problems (e.g., ulcers)
• cognitive problems (learning difficulties, memory, perception, and problem-solving) or mental problems
• kidney problems (e.g., kidney failure or kidney stones)
• eye problems (e.g., narrow-angle glaucoma)

Excessive sweating

If you sweat excessively during treatment with Salagen, drink more fluids. If you are unable to drink enough fluids, consult your doctor, as you may suffer from dehydration and organ damage if the situation continues.

Children and adolescents

This medicine should not be given to children or adolescents under 18 years of age.

Other medicines and Salagen

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• beta-blockers (medicines used to treat high blood pressure, heart problems, or eye problems)
• medicines for diarrhea (e.g., atropine)
• medicines for asthma (e.g., ipratropium inhalers)
• medicines that activate the so-called parasympathetic nervous system (e.g., some medicines for glaucoma, nervous system, or mental illnesses, Alzheimer's disease, or medicines used to accelerate intestinal transit)
• medicines that are metabolized by a liver enzyme called CYP2A6, such as the blood pressure-lowering medicine irbesartan or blood-thinning medicines (warfarin, dicumarol).

If you are not sure if any of your medicines 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 plan to become pregnant, consult your doctor before taking this medicine.

Pregnancy

Salagen should not be usedduring pregnancy unless your doctor has recommended it.

If you are of childbearing age, you should use effective contraception to prevent pregnancy while taking this medicine. Ask your doctor for advice.

Breastfeeding

It is not known whether pilocarpine is excreted in human milk. Your doctor will tell you whether you should stop taking Salagen or stop breastfeeding.

Fertility

This medicine may affect fertility in men and women. If you plan to have a child, consult your doctor before using this medicine.

Driving and using machines

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

3. How to take Salagen

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

• In patients who have been treated with radiotherapy for head or neck cancer:

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

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

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

• Patients with impaired liver function:

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

Method of administration

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 in the evening.

Duration of treatment

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

If you take more Salagen than you should

If you have accidentally taken too many Salagen tablets, talk to a doctor immediately. You may need medical attention or urgent hospitalization.

The symptoms of overdose may include cramps, diarrhea, nausea, and vomiting, involuntary passage of feces and urine, sweating, salivation, increased bronchial secretions, constriction of the pupil of the eye, slow heartbeats, low blood pressure, muscle spasms or contractions, generalized weakness.

If you forget to take Salagen

Do not take a double dose to make up for forgotten doses.

If you stop taking Salagen

Do not stop treatment unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• flu-like symptoms
• sweating
• headache
• need to urinate more frequently

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 (feeling that the heart is beating faster, stronger, or irregularly)
• tearful eyes; blurred or 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 substance pilocarpine hydrochloride:

• breathing difficulties
• stomach or abdominal spasms
• changes in heart rhythm, such as slow heart rate (bradycardia), fast heart rate (tachycardia), irregular heartbeats (arrhythmia), changes in heart conduction that prevent it from working normally (atrioventricular block),
  • severe drop in blood pressure that can cause unconsciousness (shock)

• low blood pressure
• tremors
• 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 side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet.

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

5. Storage of Salagen

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

Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date is the last day of the month shown.

Do not store above 25°C.

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

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste.

Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Salagen

• The active substance is pilocarpine hydrochloride. Each Salagen 5 mg film-coated tablet contains 5 mg of pilocarpine hydrochloride.
• The other ingredients 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 pack contents

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

The tablets are packaged in blisters and come in boxes containing 14, 21, 28, or 84 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Merus Labs Luxco II S.à.R.L.

208, Val des Bons Malades

L-2121 Luxembourg

Luxembourg

Manufacturer

Norgine BV,

Antonio Vivaldistraat 150,

1083 HP Amsterdam,

Netherlands

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2ª Planta

28046 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

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

Date of last revision of this leaflet:07/2023

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