ARTANE 2 mg Tablet

Зміст інструкції

1. ARTANE 2 mg tablets
   1. What is ARTANE 2 mg tablets and what it is used for
   2. What you need to know before you take 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

ARTANE 2 mg tablets

Triesifenidile
Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ARTANE 2 mg tablets is and what it is used for
• 2. What you need to know before you take 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 is ARTANE 2 mg tablets and what it is used for

ARTANE contains the active ingredient 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 decreases sialorrhea (increased salivation) which accompanies Parkinson's disease.

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

Do not take ARTANE 2 mg tablets:

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

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

• If you suffer from heart, kidney, or liver disorders.
• If you are elderly, the dosage must be reduced and careful monitoring is necessary. Regular gonioscopy (examination to assess the condition of the outflow pathways of intraocular fluids) and intraocular pressure checks are recommended.

Other medicines and ARTANE 2 mg tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
The effect of ARTANE is increased when used together with L-dopa (medicine used against
Parkinson's disease).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The use of ARTANE during pregnancy and breastfeeding should only be considered if the
expected benefit for the mother outweighs the risk to the fetus, therefore only in cases of actual need and under the
direct control of the doctor.

Driving and using machines
ARTANE may cause drowsiness and alter reaction times. Caution is recommended if you need to
drive vehicles or operate machinery.

ARTANE 2 mg tablets with food and drink

• If you suffer from intense salivation, take the ARTANE tablet after meals.
• If you suffer from pronounced dry mouth, take the ARTANE tablet before meals, provided this does not cause nausea. Dry mouth can be mitigated by drinking frequent small sips of water or using candies or chewing gum.

3. How to take ARTANE 2 mg tablets

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
ARTANE must be administered orally starting with a dose of 1 tablet of 2 mg, 2 or 3
times a day, with meals.
Doses of 6-10 mg per day are usually sufficient to obtain good therapeutic results.
In the case of Parkinson's disease, higher doses, from 12 to 15 mg per day, are sometimes necessary. Doses
higher than 20 mg are generally poorly tolerated and are only useful in rare cases.
If ARTANE is used in association with other anti-Parkinsonian drugs, 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 intoxication.
If you accidentally take/ingest an excessive dose of this medicine, immediately notify your
doctor or go to the nearest hospital.

If you forget to take ARTANE 2 mg tablets
Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The appearance of the following effects requires discontinuation of treatment:

• nausea,
• vomiting,
• mental disorders

The most common side effects are:

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

The following have also been reported:

• nausea,
• vomiting,
• headache.

In patients predisposed to angle closure:

• glaucoma attack (increased pressure inside the eye).

In patients with prostatic hypertrophy:

• urinary retention.

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

Following the administration of doses higher than 12 mg or in predisposed patients(e.g. elderly or
patients suffering from ongoing mental disorders):

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.
You can also report side effects directly through the national reporting system
at www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store ARTANE 2 mg tablets

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

6. Contents of the pack and other information

What ARTANE 2 mg tablets contain
The active ingredient is: trihexyphenidyl hydrochloride ……………………. 2 mg
per tablet
The other ingredients are: pregelatinized corn starch, corn starch, dibasic calcium 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 blisters.

Marketing Authorisation 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