Artane 5 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Artane is and what it is used for
- What you need to know before taking Artane
- How to take Artane
- Possible side effects
- How to store Artane
- Contents of the pack and other information
1. What Artane is and what it is 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 symptoms of extrapyramidal reactions (such as involuntary movements, restlessness, 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 to any of the components of this medicine (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 condition).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Artane, especially:
- if you have previously had intestinal obstructive disease (such as severe constipation) or urinary retention.
- if during treatment you notice allergic reactions or any signs 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 periods of high temperatures, as it may cause reduced or absent sweating.
- if you have any eye problems.
- if you have dementia, as cognitive impairment may worsen.
- if you suffer from a disease called myasthenia gravis (a condition characterized by muscle weakness).
- if you experience abnormal movements of the face and tongue, as these may be signs of a serious condition known as tardive dyskinesia.
- if you are elderly.
If you notice any psychological disturbances, consult your doctor immediately.
During prolonged treatment with Artane, your doctor may carry out regular blood tests and periodic measurements of intraocular pressure.
Do not stop treatment suddenly without medical advice.
Other medicines and Artane
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 likelihood of adverse effects.
This is especially important in the case of:
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Anticholinergic medicines: (tricyclic antidepressants such as imipramine, most H1 antihistamines, atropine-like antispasmodics, other anticholinergic antiparkinsonian agents, disopyramide, phenothiazine neuroleptics).
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MAO inhibitors, amantadine, and certain tricyclic antidepressants.
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Antacids or antidiarrheal agents: administration of these medicines should be avoided within one hour after taking Artane.
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Levodopa: simultaneous use is not recommended if there is a history of psychosis.
Taking Artane with food, drinks, and alcohol
During treatment, avoid alcoholic beverages. Alcohol may enhance the occurrence of adverse effects.
Artane may be taken with food.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
It is preferable not to take this medicine during pregnancy.
You must not take Artane tablets while breastfeeding.
Driving and using machines
Artane tablets may cause vision problems or reduced attention, which could make driving or operating tools or machinery dangerous.
Artane contains maize starch, dibasic calcium phosphate, and magnesium stearate.
3. How to take Artane
Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The dose is variable and must be adjusted according to the severity of symptoms and the individual susceptibility of each patient.
In general, 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 must not be used in children.
If you feel that the effect of Artane is too strong or too weak, inform your doctor or pharmacist.
Artane tablets should be swallowed whole with water after meals. The score line is intended solely for dividing the tablet if you have difficulty swallowing it whole.
If you take more Artane than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department and bring the medicine with you. You may also call the Toxicology Information Service at telephone number 91.562.04.20, stating the name of the medicine 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 almost time for your next dose. Do not take a double dose to make up for a missed dose.
If you stop taking Artane
Do not stop treatment unless instructed by your doctor. Abruptly stopping treatment may lead to worsening of your symptoms. If you need to discontinue Artane, your doctor will advise you on the best way to do so.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them. Artane may cause you:
- Dry mouth
- Constipation
- Vision problems
- Urinary retention
- Agitation
- Confusion
- Hallucinations
- Feelings of optimism
- Inability to sleep or rest
- Forgetfulness
- Paranoid ideation (concern that something bad is happening without any reason).
These effects are more frequent in elderly individuals, who are more sensitive to the treatment and may occasionally develop agitation or psychological problems. (See section 2 Warnings).
Other effects that may occur include:
- Inflammation of the supporting tissue of the teeth due to dry mouth
- Skin rash
- Colon dilation
- Intestinal obstruction
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a pharmacy’s SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Artane 2 mg tablets
- The active substance is trihexyphenidyl. Each tablet contains 2 mg of trihexyphenidyl hydrochloride.
- The other components are: maize starch, dibasic calcium phosphate, 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: maize starch, dibasic calcium phosphate, and magnesium stearate.
Appearance of the product and contents of the pack
Artane is available in transparent PVC/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: +39 0382 422008
e-mail: [email protected]
This leaflet was approved in April 2022
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.