ARTANE

Package leaflet: Information for the user

ARTANE 2 mg tablets

Trihexyphenidyl
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ARTANE 2 mg tablets are and what they are used for
2. What you need to know before taking ARTANE 2 mg tablets
3. How to take ARTANE 2 mg tablets
4. Possible side effects
5. How to store ARTANE 2 mg tablets
6. Contents of the pack and other information

1. What ARTANE 2 mg tablets are and what they are used for

ARTANE contains the active substance trihexyphenidyl.
It is indicated:

• for the treatment of postencephalitic Parkinson's disease,
• for the treatment of diseases whose symptoms are similar to those of Parkinson's disease (parkinsonism).

It reduces both tremor and rigidity.
It also reduces sialorrhea (increased salivation) associated with Parkinson's disease.

2. What you need to know before taking ARTANE 2 mg tablets

Do not take ARTANE 2 mg tablets:

• if you are allergic to trihexyphenidyl or to any of the other ingredients of this medicine (listed in section 6),
• if you have glaucoma (increased intraocular pressure),
• if you have prostatic hypertrophy (enlarged prostate).

Warnings and precautions
Talk to your doctor or pharmacist before taking ARTANE 2 mg tablets.
Consult your doctor if:

• You have heart, kidney, or liver disorders.
• You are elderly, as dosage reduction is recommended and careful monitoring is required. Regular gonioscopy (an examination to assess the outflow pathways of intraocular fluids) and intraocular pressure checks are advised.

Other medicines and ARTANE 2 mg tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of ARTANE is increased when used concomitantly with L-dopa (a medicine used in the treatment of Parkinson’s disease).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of ARTANE during pregnancy and breastfeeding should only be considered if the expected benefit to the mother outweighs the potential risk to the fetus; therefore, only when clearly necessary and under direct medical supervision.

Driving and using machines
ARTANE may cause drowsiness and alter reaction times. Exercise caution if driving vehicles or operating machinery.

ARTANE 2 mg tablets with food and drink

• If you suffer from excessive salivation, take the ARTANE tablet after meals.
• If you suffer from marked dry mouth, take the ARTANE tablet before meals, provided this does not cause nausea. Dry mouth may be relieved by frequently drinking small sips of water or by using sugar-free candies or chewing gum.

3. How to take ARTANE 2 mg tablets

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
ARTANE should be administered orally, starting with a dose of 1 tablet of 2 mg, 2 or 3
times daily, taken with meals.
Doses of 6–10 mg daily are usually sufficient to achieve good therapeutic results.
In Parkinson's disease, higher doses may sometimes be required, ranging from 12 to 15 mg daily. Doses
exceeding 20 mg are generally poorly tolerated and are useful only in rare cases.
When ARTANE is used in combination with other antiparkinsonian medicines, small doses are sufficient.
If you take more ARTANE 2 mg tablets than you should
In case of acute overdose, the symptoms and signs are those of atropine poisoning.
In the event of accidental ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take ARTANE 2 mg tablets
Do not take a double dose to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The occurrence of the following effects requires discontinuation of treatment:

• nausea,
• vomiting,
• mental disturbances.

The most common adverse reactions are:

• dry mouth,
• mydriasis (dilation of the pupil),
• cycloplegia (paralysis of the eye muscle),
• constipation,
• tachycardia (increased heart rate),
• urinary retention,
• mental disturbances (psychiatric disorders).

The following have also been reported:

• nausea,
• vomiting,
• headache (cephalalgia).

In patients predisposed to angle closure:

• acute glaucoma attack (increased intraocular pressure).

In patients with prostatic hypertrophy:

• urinary retention.

In patients suffering from gastrointestinal disorders: monitoring should be implemented to prevent the occurrence of intestinal obstruction.

Following administration of doses exceeding 12 mg or in predisposed patients (e.g. elderly patients or patients with pre-existing mental disorders):

• mental disturbances characterized by confusion and excitement,
• in more severe cases: delirium, hallucinations, and paranoid reactions.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor or pharmacist.
You may also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. How to store ARTANE 2 mg tablets

This medicinal product does not require any special storage precautions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ARTANE 2 mg tablets contain
The active substance is: trihexyphenidyl hydrochloride ……………………. 2 mg
per tablet
The other components are: pregelatinized maize starch, maize starch, calcium hydrogen phosphate, magnesium
stearate

Description of the appearance of ARTANE 2 mg tablets and contents of the pack
ARTANE is presented in a carton containing 50 tablets in blister packs.

Marketing Authorization Holder
Teofarma S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)

Manufacturer
Teofarma S.r.l.
Viale Certosa, 8/A
27100 Pavia