Package Insert: Information for the User

Pilocarpine Apotheke 5 mg Film-Coated Tablets EFG

pilocarpine hydrochloride

Read this package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only and should not be given to others, 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 package insert. See section 4.

Pilocarpina Apotheke contains the active ingredient pilocarpine, which belongs to a group of medications called cholinergic or parasympathomimetic agents.

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

Pilocarpina Apotheke is used:

• if you have received radiation therapy for head or neck cancer, and you notice your mouth is very dry
• if you have been diagnosed with a condition known as Sjögren's syndrome, and you notice dryness in your eyes and/or mouth

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

Do not take Pilocarpina Apotheke

• If you are allergic to hydrochloride pilocarpine or to 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 pilocarpine. 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 you are affected by any of the cases mentioned above, inform your doctor before taking pilocarpine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take pilocarpine.

Inform your doctor before taking pilocarpine 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 or gallbladder problems (for example, 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 pilocarpine, drink more liquids. If you are unable to drink enough liquids, consult your doctor as excessive sweating may lead to 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 Pilocarpina Apotheke

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 whether 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

This medication should not be used during pregnancy unless your doctor recommends it.

If you are of childbearing age, you should 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 pilocarpine 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

Pilocarpine 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 for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

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

• The initial recommended dose in adults is one 5 mg tablet three times a day.
• Make sure to take your last tablet of the day with dinner.

For patients who have been 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.

In accordance with 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) 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.
• In accordance with how you respond to treatment, your doctor may gradually increase your dose to the recommended daily dose.

Method of administration

Pilocarpineshould only be taken orally.

Take the pilocarpine 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.

Duration of treatment

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 Pilocarpine Apotheke than you should

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

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

In case of overdose or accidental ingestion, go to a medical center immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Pilocarpine Apotheke

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

If you interrupt treatment with Pilocarpine Apotheke

Do not interrupt 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 vision or abnormal vision; red and swollen eyes (conjunctivitis) and eye pain

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

• sudden need to urinate
• flatulence (gas)

Other side effects of the active ingredient pilocarpine:

• breathing difficulties
• stomach or abdominal spasms
• changes in heart rhythm, such as slow heart rate (bradycardia), rapid heart rate (tachycardia), irregular heartbeats (arrhythmia), and 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
• trembling
• changes in mental state including memory disorders, hallucinations (seeing or hearing something that is not real), agitation, mood changes, and confusion

Reporting 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 to the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

• Each tablet contains 5 mg of pilocarpine hydrochloride as the active ingredient.
• The other components are microcrystalline cellulose, pregelatinized cornstarch, anhydrous colloidal silica, and stearic acid. The coating is composed of Opadry white, OY-7300, (contains hypromellose, titanium dioxide (E171), and macrogol 400).

Appearance of the product and contents of the package

Coated, biconvex tablets with a diameter of approximately 6.1 mm, marked with "P5" on one face and smooth on the other.

Pilocarpina Milstein is presented in blisters and boxes containing 14 or 84 coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder

Milstein C.V.

Patroonsweg, 20e Zeewolde, Flevoland

3892 DB

Netherlands

Responsible manufacturer

Tiofarma B.V.

Benjamin Franklinstraat 5-10

Oud-Beijerland

3261 LW

Netherlands

or

Infarmade S.L.

C/ Torre de los Herberos nº 35

41703 - Dos Hermanas, Sevilla

Spain

This medicine is authorized in the Member States of the European Economic Area with the following denominations:

Croatia: Pilokarpinklorid Milstein 5 mg filmom obložene tablete

Germany: Pilocarpinhydrochlorid Milstein 5 mg Filmtabletten

Last review date of this leaflet: October 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/