Pilocarpine Apotheke 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pilocarpine Apotheke 5 mg film-coated tablets EFG

pilocarpine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and must 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Pilocarpine Apotheke contains the active substance pilocarpine, which belongs to a group of medicines called parasympathomimetic agents 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 experience a very dry mouth
• if you have been diagnosed with a condition known as Sjögren's syndrome and experience dryness in your eyes and/or mouth

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

2. What you need to know before taking Pilocarpine Apotheke

Do not take Pilocarpine Apotheke

• If you are allergic to pilocarpine hydrochloride or to 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 acting like pilocarpine. Consult your doctor if you have any doubts.
• If you have a condition that requires avoiding constriction of the eye's pupil (for example, acute inflammation of the iris), or if you have inflammation of the iris (iritis)

If any of the above conditions apply to you, inform your doctor before taking pilocarpine.

Warnings and precautions

Talk to 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 (for example, asthma, chronic bronchitis, and/or chronic obstructive pulmonary disease)
• Serious heart problems (for example, heart failure, irregular pulse)
• Gallbladder or bile duct problems (for example, gallstones)
• Stomach or intestinal problems (for example, ulcers)
• Cognitive problems (difficulties with learning, memory, perception, and problem-solving) or mental health conditions
• Kidney problems (for example, renal failure or kidney stones)
• Eye problems (for example, 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 continued fluid loss may lead to dehydration and organ damage.

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 need to 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 conditions)
• Medicines for diarrhoea (for example, atropine)
• Medicines for asthma (for example, ipratropium inhalers)
• Medicines that activate the so-called parasympathetic nervous system (for example, certain medicines for glaucoma, nervous system disorders, mental health conditions, Alzheimer's disease, or medicines used to speed up intestinal transit)
• Medicines metabolized by a liver enzyme called CYP2A6, for example, the blood pressure-lowering medicine irbesartan or medicines used to prevent blood clotting (warfarin, dicumarol)
• If you are unsure whether 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 become pregnant, consult your doctor before taking this medicine.

Pregnancy

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

If you are of childbearing age, you should use an effective method of contraception to prevent pregnancy while taking this medicine. Seek advice from your doctor.

Breastfeeding

It is unknown whether pilocarpine is excreted in human milk. Your doctor will advise you whether you should discontinue treatment with pilocarpine or interrupt breastfeeding.

Fertility

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

Driving and using machines

Pilocarpine may cause dizziness or affect your vision, particularly causing difficulty seeing properly at night. If this occurs, do not drive or operate tools or machinery.

3. How to take Pilocarpine Apotheke

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

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

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

In patients who have been diagnosed with Sjögren's syndrome:

• The recommended dose in adults is one 5 mg tablet four times daily.
• Make sure to take your last tablet of the day just before bedtime.

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.

Patients with impaired liver function:

• If you have cirrhosis (liver disorder), your doctor will instruct you to start 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.

Method of administration

Pilocarpine must 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 one 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 notice 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, speak to a doctor immediately. You may require urgent medical attention or hospital admission.

Symptoms of overdose may include stomach cramps, diarrhea, nausea and vomiting, involuntary passage of stools and urine, sweating, salivation, increased bronchial secretions, pupillary constriction (miosis), slow heart rate, low blood pressure, muscle spasms or contractions, and generalized weakness.

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

If you forget to take Pilocarpine Apotheke

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

If you stop taking Pilocarpine Apotheke

Do not stop treatment unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• flu-like symptoms
• sweating
• headache
• increased need to urinate

Common adverse 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 of age)
• diarrhea; constipation
• indigestion; abdominal pain; nausea; vomiting
• increased salivation
• flushing; increased blood pressure
• palpitations (sensation of the heart beating faster, stronger, or irregularly)
• watery eyes; blurred or abnormal vision; red and swollen eyes (conjunctivitis); eye pain

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

• sudden urge to urinate
• flatulence (gas)

Other adverse effects of the active substance pilocarpine:

• breathing difficulties
• stomach or abdominal cramps
• changes in heart rhythm, such as slow heart rate (bradycardia), fast heart rate (tachycardia), irregular heartbeat (arrhythmia), conduction disturbances in the heart that prevent it from functioning normally (atrioventricular block)
• severe drop in blood pressure that may lead to unconsciousness (shock)
• low blood pressure
• tremor
• changes in mental state including memory disorders, hallucinations (seeing or hearing things that are not real), agitation, mood changes, and confusion

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pilocarpine Apotheke

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Composition of Pilocarpine Apotheke

• Each tablet contains 5 mg of pilocarpine hydrochloride as the active substance.
• The other components are microcrystalline cellulose, pregelatinized starch (from corn), colloidal anhydrous silica, and stearic acid. The coating consists of Opadry White, OY-7300 (containing hypromellose, titanium dioxide (E171), and macrogol 400).

Appearance of the product and contents of the container

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

Pilocarpine Apotheke is available in blisters and cartons containing 14 or 84 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Apotheke Laboratorios, S.L.
Paseo de la Castellana 40, 8th floor
28046 - Madrid
Spain

Manufacturer Responsible

Infarmade S.L.
C/ Torre de los Herberos nº 35
41703 - Dos Hermanas, Seville
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Pilocarpinhydrochlorid Bay Pharma 5 mg Filmtabletten

Date of the most recent review of this leaflet: October 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/