ARTANE 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Artane 2 mg Tablets

Artane 5 mg Tablets

Trihexyphenidyl, hydrochloride

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of thepackage leaflet:

1. What Artane is and what it is used for
2. What you need to know before taking Artane
3. How to take Artane
4. Possible side effects
5. Storage of Artane
6. Package contents and additional information

1. What Artane is and what it is used for

Artane belongs to a group of medications known as antiparkinsonian agents.

Artane is used to treat symptoms of Parkinson's disease and symptoms of extrapyramidal reactions (such as involuntary movements, agitation, muscle rigidity, and muscle contractions) caused by other medications.

2. What you need to know before taking Artane

Do not take Artane:

• if you are allergic to the active substance or any of the components of this medication (listed in section 6).
• if you have narrow-angle glaucoma (increased pressure inside the eye).
• if you have difficulty urinating (due to prostate problems or other causes)
• if you have decompensated heart disease (heart disease)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Artane, especially:

• if you have had intestinal obstruction (such as severe constipation) or urinary retention.
• if during treatment you observe the appearance of allergic reactions or signs of intolerance to the medication.
• if you have high blood pressure
• if you have kidney, heart, or liver problems
• if you need to take the medication during hot weather, as it may cause decreased or lost sweating.
• if you have eye problems
• if you have dementia, as it may worsen intellectual deterioration.
• if you suffer from myasthenia gravis (a disease characterized by muscle weakness)
• if you have abnormal movements in the face and tongue, which may be a sign of a serious disease known as tardive dyskinesia
• if you are an elderly person.

If you notice any mental changes, consult your doctor immediately.

During prolonged treatment with Artane, your doctor may perform regular blood tests and periodic measurements of intraocular pressure.

Do not stop treatment suddenly without consulting your doctor.

Other medications and Artane

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Some medications may affect how Artane works, or Artane may affect the effectiveness of other medications taken at the same time or increase the risk of side effects.

This is especially important in the case of:

• Atropine-like medications: (imipramine antidepressants, most H1 antihistamines, atropine-like antispasmodics, other antiparkinsonian anticholinergic agents, disopyramide, phenothiazine neuroleptics).

• MAO inhibitors, amantadine, and certain tricyclic antidepressants.

• Antacids or anti-diarrheal medications, administration of these medications should be avoided during the hour following administration of Artane.

• Levodopa, concomitant use is not recommended if there is a history of psychosis.

Taking Artane with food, drinks, and alcohol

Avoid alcoholic beverages during treatment. The effect of alcohol may increase the risk of side effects.

Artane can be taken with meals.

Pregnancy, breastfeeding, and fertility

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

It is preferable not to take this medication during pregnancy.

Do not take Artane tablets if you are breastfeeding your child.

Driving and using machines

Artane tablets may cause vision or attention problems, making it dangerous to drive or operate tools or machines.

Artane contains cornstarch, calcium phosphate dibasic, and magnesium stearate

3. How to take Artane

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

The dose is variable and should be adjusted according to the severity of the problems and individual patient susceptibility.

Generally, the initial dose will be 1 tablet of 2 mg per day. Your doctor may gradually increase your dose over 3-5 days to approximately 5-10 mg divided into several doses per day. The maximum daily dose is 15 mg.

Artane is available in 2 mg and 5 mg tablets

Use in children

Artane should not be used in children.

If you think the effect of Artane is too strong or too weak, tell your doctor or pharmacist.

Artane tablets should be swallowed whole with water after meals. The score line is only for breaking the tablet if you find it difficult to swallow whole.

If you take more Artane than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or contact the emergency department of the nearest hospital and bring the medication with you. You can also call the Toxicology Information Service at 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Artane

If you forget to take a dose, take it as soon as you remember, unless it is time for the next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Artane

Do not stop treatment unless your doctor tells you to. If you stop treatment suddenly, you may experience worsening of your symptoms. If you need to stop taking Artane, your doctor will tell you the best way to do it.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. Artane may cause:

• Dry mouth
• Constipation
• Vision problems
• Urinary retention
• Agitation
• Confusion
• Hallucinations
• Feelings of optimism
• Insomnia or restlessness
• Forgetfulness
• Paranoid delusions (concern that something bad is happening without reason).

These effects are more common in elderly people who are more sensitive to treatment and may exhibit agitation or mental problems occasionally. (See section 2 Warnings).

Other effects that may appear are:

• Inflammation of the dental supporting tissue due to dry mouth
• Rash
• Colon dilation
• Intestinal obstruction

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Artane

Keep this medication out of sight and reach of children.

Do not store above 30°C.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Artane 2 mg tablets

• The active substance is trihexyphenidyl. Each tablet contains 2 mg of trihexyphenidyl hydrochloride.
• The other components are: cornstarch, calcium phosphate dibasic, and magnesium stearate.

Composition of Artane 5 mg tablets

• The active substance is trihexyphenidyl. Each tablet contains 5 mg of trihexyphenidyl hydrochloride.

The other components are: cornstarch, calcium phosphate dibasic, and magnesium stearate.

Appearance of the product and package contents

Artane is presented in PVC transparent/Aluminum blister packs containing 25 tablets.

Marketing authorization holder and manufacturer

Teofarma S.r.l.

Via F.lli Cervi 8

27010 VALLE SALIMBENE (Pavia)

ITALY

Phone: 0039 0382 422008

e-mail: [email protected]

This package leaflet was approved in April 2022

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