Prospect: information for the user

Artane 2 mg tablets

Artane 5 mg tablets

Trihexifenidilo, hydrochloride

Read this prospect carefully before starting to take this medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as 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 prospect. See section 4.

Content of theprospect:

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

Artane belongs to a group of medications known as antiparkinsonians.

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

Do not take Artane:

• if you are allergic to the active ingredient or to any of the components of this medication (listed in section 6).
• if you have closed-angle glaucoma (increased pressure inside the eye).
• if you have difficulty urinating (prostatic or other cause)
• 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 (severe constipation) or urinary retention.
• if during treatment you observe the appearance of allergic reactions or any sign of intolerance to the medication.
• if you have high blood pressure
• if you have any kidney, heart, or liver problems
• if you must take the medication in hot weather seasons, as it may cause decreased or loss of sweating.
• if you have any eye problems
• if you have dementia, as it may worsen the intellectual decline.
• if you have a disease called myasthenia gravis (a disease characterized by muscle weakness)
• if you have abnormal movements in the face and tongue, as they may be a sign of a serious disease called 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 analytical tests and periodic determinations of intraocular pressure.

Do not stop treatment suddenly without consulting your doctor.

Other medications and Artane

Inform your doctor or pharmacist if you are using, have used recently, 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 likelihood of adverse effects.

This is especially important in the case of:

• Atropinic medications: (imipraminic antidepressants, most H1 antihistamines, atropinic antispasmodics, other antiparkinsonian anticholinergic medications, disopyramide, phenothiazine neuroleptics).

• MAO inhibitors, amantadine, and certain tricyclic antidepressants.

• Antacids or anti-diarrheal medications, avoid administering these medications during the hour following Artane administration.

• Levodopa, do not recommend simultaneous use if there is a history of psychosis.

Artane with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may potentiate the appearance of adverse effects.

Artane can be taken with meals.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, 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 operating machines

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

Artane contains Cornstarch, Calcium phosphate dibasic, and Magnesium stearate

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

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

Generally, the initial dose will be 1 tablet of 2 mg per day. Your doctor may increase your dose gradually 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 tablets of 2 and 5 mg.

Use in children

Artane should not be used in children.

If you estimate that the action of Artane is too strong or too weak, inform your doctor or pharmacist.

Artane tablets should be swallowed whole with water after meals. The groove is only for breaking the tablet if it is 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 nearest hospital emergency service and bring the medication with you. You can also call the Toxicological Information Service at Teléfono 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 to take the next dose. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Artane

Do not interrupt treatment unless your doctor tells you to. If you interrupt 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 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 may experience them. Artane may cause you:

• Dry mouth
• Constipation
• Visual problems
• Urinary retention
• Restlessness
• Confusion
• Hallucinations
• Feelings of euphoria
• Inability to sleep or rest
• Memory loss
• Paranoid illusions (concern that something bad is happening without reason).

These effects are more frequent in older people who are more sensitive to treatment and may exhibit restlessness or psychological problems from time to time. (See section 2 Warnings).

Other effects that may appear are:

• Periodontal inflammation due to dry mouth
• Skin eruption
• Colon dilation
• Intestinal obstruction

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it ispossibleadverse effects that do not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: 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 above30°C.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Artane 2 mg tablets

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

Composition of Artane 5 mg tablets

• The active ingredient is trihexifenidilo. Each tablet contains 5 mg of trihexifenidilo hydrochloride.

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible manufacturer

Teofarma S.r.l.

Via F.lli Cervi 8

27010 VALLE SALIMBENE (Pavia)

ITALY

Telephone: 0039 0382 422008

e-mail: [email protected]

This leaflet was approved in April 2022

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