Package Insert: Information for the Patient

Kemadren 5 mg Tablets

procyclidine hydrochloride

Read this package insert carefully before starting to take this medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribedonlyfor you and should not be given to others even if they have the same symptomsas you, 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.

Kemadren contains an active substance called procyclidine hydrochloride. It belongs to a group of medications called anticholinergics.

This medication acts by canceling out the substance called acetylcholine produced by our body.

Kemadren is used for:

• To treat and alleviate the symptoms of Parkinson's disease (such as muscle stiffness, paralysis, tremor, speech, writing, and walking problems, excessive saliva production, drooling, sweating, involuntary eye movement, and depression).
• To prevent side effects known as "extrapyramidal effects" caused by some medications. They may include symptoms similar to those produced by Parkinson's disease, as well as restlessness or unusual head and body movements.

Do not take Kemadren

• if you are allergic to procyclidine hydrochloride or any of the other ingredients of this medication (listed in section 6),
• if you have a condition caused by too much pressure in the eye called closed-angle glaucoma,
• if you have problems urinating (retention),
• if you have constipation.

Do not take Kemadren if you have any of the above symptoms. If you are unsure, consult your doctor before starting to take Kemadren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Kemadren if:

• You have an enlarged prostate,
• You have a mental illness and are taking Kemadren to control the side effects of other medications. In some cases, people taking this medication may experience a psychotic episode,
• If you are elderly, carefully monitor the dose to avoid side effects,
• If you have any liver or kidney disease,
• If you are prone to glaucoma (a group of diseases that damage the optic nerve),
• If you are prone to diseases that obstruct the gastrointestinal tract (complete or partial obstruction of both the large and small intestines),
• Some patients taking Kemadren to control side effects of other medications may experience involuntary repetitive body movements. If this happens, your doctor may decide to lower the dose.

If you are unsure whether the above applies to your case, consult your doctor or pharmacist before starting to take Kemadren.

Children

This medication is not suitable for use in children.

Taking Kemadren with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription and/or herbal medicines before taking Kemadren.

Especially, inform your doctor if you are taking any of the following medications:

• Mental health medications, such as monoamine oxidase inhibitors, tricyclic antidepressants, paroxetine, clozapine, or phenothiazines.
• Medications for dementia, including Alzheimer's disease (such as memantine or tacrine).

• Antihistamines for treating hay fever and allergies.
• Disopyramide, quinine, and nitrate tablets (including tablets that dissolve under the tongue) used to treat heart problems.
• Levodopa and amantadine used in Parkinson's disease.
• Cisapride, domperidone, and metoclopramide, used to treat nausea, vomiting, and indigestion.
• Nefopam, used to treat pain.
• Ketoconazole to treat fungal infections.
• If you are taking medications to treat psychosis, such as chlorpromazine in combination with Kemadren, you should be aware that this medication may cause fever if you travel to a tropical (hot and humid) climate.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Taking Kemadren may cause blurred vision, dizziness, confusion, or feeling disoriented. If this happens, do not drive, do not use tools, or operate machinery.

Kemadren contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Kemadren contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

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

• Take the tablets with a glass of water.
• You can take Kemadren at any time of the day, with or without food. Some people feel less dizzy if they take it during meals.
• The tablet can be divided into equal doses.

In the treatment of Parkinson's disease

• The recommended initial dose is half a tablet three times a day.
• Your doctor may increase the dose by adding half or a tablet each day until an effect is seen. This is known as the maintenance dose.
• The usual maintenance dose is 15-30 mg (3 to 6 tablets) per day.
• The maximum dose that your doctor will decide to prescribe is 60 mg (12 tablets) per day.
• Although the dose is usually taken three times a day, your doctor may ask you to take a fourth dose before bedtime.

In the treatment of uncontrolled body movements (extrapyramidal symptoms) caused by taking other medications:

• The recommended initial dose is half a tablet three times a day.
• Your doctor may increase the dose by adding half a tablet per day until an effect is seen. The usual daily maintenance dose is 10-30 mg (2 to 6 tablets).
• Your doctor may decide to stop your treatment with Kemadren after 3-4 months to see if your side effects continue.
• If you need to take Kemadren for a longer period, your doctor may decide to interrupt treatment from time to time.

Older adults

Carefully monitor the dose in older adults to avoid side effects.

Use in children

Generally, the use of Kemadren tablets in children is not recommended.

If you take more Kemadren than you should

If you take more than you should, consult your doctor or go to the hospital immediately. Bring the medication packaging with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Kemadren

If you forget to take a dose, take the doses as soon as possible. Do not take a double dose to compensate for the missed doses. Take the next dose at the usual time. If you have trouble remembering to take the tablets, inform your doctor or pharmacist.

If you interrupt treatment with Kemadren

Do not stop taking Kemadren without consulting your doctor.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them. The following adverse effects may occur with this medication.

If you are taking a medication for a mental illness (called a neuroleptic) at the same time as Kemadren:

• You may develop involuntary movements of the face and tongue (called tardive dyskinesia). It may be necessary to adjust the dosage of either of your medications.
• Unusual body movements, especially in the hands, arms, and legs, which you already experienced with the medication for your mental illness and may be worsened by taking Kemadren.

If any of these occur, inform your doctor immediately.

Frequent(may affect up to 1 in 10 patients):

• Urination problems (urinary retention)
• Blurred vision
• Dry mouth
• Constipation

Occasional(may affect up to 1 in 100 patients):

• Nausea or vomiting
• Gingivitis (inflammation of the gums)
• Dizziness, nervousness, confusion, disorientation, decreased concentration or memory, hearing voices or seeing things that are not there (hallucinations), anxiety, agitation (irritability)
• Skin eruptions

Rare(may affect up to 1 in 1,000 patients):

• Psychotic disorder, which includes symptoms that occur together such as: dizziness, confusion, decreased concentration or memory, disorientation, hearing voices or seeing things that are not there (hallucinations), anxiety, agitation (irritability).

If you consider any of the adverse effects you are experiencing to be severe, even if they are not listed in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not store at a temperature above 25 °C.
• Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.
• .
• Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Kemadren Composition

The active ingredient is procyclidine hydrochloride. Each tablet contains 5 mg of the active ingredient.

The other components are: lactose monohydrate, sodium glycocolate starch from potato (type A), povidone, and magnesium stearate.

Product appearance and packaging contents

Kemadren 5 mg tablets are white, round, biconvex, with a breaking line on one face, engraved with KT above the breaking line and 05 below the breaking line, and with a groove on the other face. They are presented in amber glass bottles with a polyethylene screw cap containing 25 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aspen Pharma Trading Limited

3016 Lake Drive

Citywest Business Campus

Dublín 24, Ireland

Tel:+34 952010137

Responsible manufacturer

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36

23843 Bad Oldesloe

Germany

Local Representative

Aspen Pharmacare España S.L.

Avenida Diagonal, 512

Planta Interior 1, Office 4

08006 Barcelona

Spain

Last review date of this leaflet:02/2023

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