ARTANE 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

Artane 2 mg Tablets

Artane 5 mg Tablets

Trihexyphenidyl, 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 symptoms are the same as yours.
• If you experience 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 thepackage leaflet:

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

1. What is Artane and what is it used for

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

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

2. What you need to know before you take Artane

Do not take Artane:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Artane, especially:

• if you have had intestinal obstruction (such as severe constipation) or urinary retention.
• if during treatment you notice the appearance of allergic reactions or any sign of intolerance to the medicine.
• if you have high blood pressure
• if you have any kidney, heart, or liver problems
• if you need to take the medicine during hot weather, as it may cause decreased or lost sweating.
• if you have any eye problems
• if you have dementia, as it may worsen intellectual deterioration.
• if you suffer from a disease called 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 medicines and Artane

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

This is especially important in the case of:

• Anticholinergic medicines: (imipramine-type antidepressants, most H1 antihistamines, antispasmodic atropine, other antiparkinsonian anticholinergic agents, disopyramide, phenothiazine neuroleptics).

• MAO inhibitors, amantadine, and certain tricyclic antidepressants.

• Antacids or anti-diarrheal medicines, administration of these medicines 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 medicine.

It is preferable not to take this medicine 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 Corn Starch, Calcium Phosphate Dibasic, and Magnesium Stearate

3. How to take Artane

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

The dose is variable and must be adapted to the intensity of the problems as well as the individual susceptibility of each patient.

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 to 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.

The 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 take the medicine with you. You can also call the Toxicology Information Service Telephone 91.562.04.20, indicating the medicine and the amount taken.

If you forget to take Artane

If you forget to take a dose, take it as soon as you remember unless it is time to take 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 abruptly, 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Artane may cause:

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

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

Other effects that may appear are:

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Artane

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

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. Contents of the pack and further information

Composition of Artane 2 mg tablets

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

Appearance and packaging

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

Telephone: 0039 0382 422008

e-mail: amministrazione@teofarma.it

This leaflet was approved in April 2022

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