PILOCARPINE APOTHEKE 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Pilocarpine Apotheke 5 mg Film-Coated Tablets EFG

pilocarpine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Pilocarpine Apotheke and what is it used for
2. What you need to know before you take Pilocarpine Apotheke
3. How to take Pilocarpine Apotheke
4. Possible side effects
5. Storage of Pilocarpine Apotheke
6. Contents of the pack and further information

1. What is Pilocarpine Apotheke and what is it used for

Pilocarpine Apotheke contains the active substance pilocarpine, which belongs to a group of medicines called parasympathomimetic or cholinergic 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.

Pilocarpine Apotheke is used:

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

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

2. What you need to know before you take Pilocarpine Apotheke

Do not take Pilocarpine Apotheke

• 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 pilocarpine. 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 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 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)
• 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 pilocarpine, drink more fluids. If you are unable to drink enough fluids, consult your doctor, as prolonged dehydration and organ damage may occur.

Children and adolescents

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

Other medicines and Pilocarpine Apotheke

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is especially important that you inform your doctor if you are taking 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, e.g., 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 are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Pilocarpine must not be used during pregnancy unless your doctor has recommended it.

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

Breastfeeding

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

Fertility

This medicine may impair fertility in men and women. If you are planning to have a child, ask your doctor for advice before taking this medicine.

Driving and using machines

Pilocarpine may cause dizziness or affect your vision, particularly at night. If this happens, do not drive or operate machinery.

3. How to take Pilocarpine Apotheke

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:

For patients who have been treated with radiotherapy 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 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 tell you to 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

Pilocarpine should 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, e.g., 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 Pilocarpine Apotheke than you should

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

Symptoms of overdose may include stomach cramps, diarrhea, nausea, and vomiting, involuntary passage of feces and urine, sweating, salivation, increased bronchial secretions, pupil constriction, slow heartbeat, 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 medicine and the amount taken

If you forget to take Pilocarpine Apotheke

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

If you stop taking Pilocarpine Apotheke

Do not stop treatment unless your doctor tells you to.

If you have any further questions on the use of this product, 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
• nasal discharge
• allergic reactions including rash and itching
• dizziness (more likely in patients over 65 years)
• 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) and 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:

• breathing difficulties
• stomach or abdominal spasms
• changes in heart rhythm, such as slow heart rate (bradycardia), fast heart rate (tachycardia), irregular heartbeat (arrhythmia), conduction disorders that prevent the heart from functioning 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pilocarpine Apotheke

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 carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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

6. Composition of Pilocarpine Apotheke

• Each tablet contains 5 mg of pilocarpine hydrochloride as the active substance.
• The other ingredients are microcrystalline cellulose, pregelatinized starch (from corn), anhydrous colloidal silica, 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 pack

Round, biconvex, film-coated tablets, approximately 6.1 mm in diameter, marked with "P5" on one side and smooth on the other.

Pilocarpine Apotheke is available in blister packs and boxes containing 14 or 84 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Milstein C.V.

Patroonsweg, 20e Zeewolde, Flevoland

3892 DB

Netherlands

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 under the following names:

Croatia:Pilokarpinklorid Milstein 5 mg filmom obložene tablete

Germany:Pilocarpinhydrochlorid Milstein 5 mg Filmtabletten

Date of last revision of this leaflet: October 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/