Altina 1 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Altina 1 mg tablets EFG
Rasagiline
Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as 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. It may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if the side effect is not listed in this leaflet. See section 4.
Contents of the leaflet
- What Altina is and what it is used for
- What you need to know before taking Altina
- How to take Altina
- Possible side effects
- How to store Altina
- Contents of the pack and other information
1. What Altina is and what it is used for
Altina contains the active substance rasagilina and is indicated for the treatment of Parkinson's disease in adults. It can be used with or without levodopa (another medicine used to treat Parkinson's disease).
In Parkinson's disease, there is a loss of dopamine-producing cells in the brain. Dopamine is a chemical compound in the brain involved in the control of movement. Rasagilina helps increase and maintain dopamine levels in the brain.
2. What you need to know before taking Altina
Do not take Altina
- If you are allergic to rasagiline or to any of the other ingredients of this medicine (listed in section 6).
- If you have severe liver problems.
Do not take the following medicines while taking Altina:
- Monoamine oxidase inhibitors (MAO inhibitors) (e.g. for the treatment of depression or Parkinson's disease, or for other indications), including prescription and non-prescription medicines and herbal products, e.g. St. John’s wort.
- Meperidine (a strong painkiller).
You must wait at least 14 days after stopping treatment with Altina before starting treatment with MAO inhibitors or meperidine.
Warnings and precautions
Talk to your doctor before taking Altina
- If you have any liver problems.
- You should speak to your doctor about any suspicious changes in your skin. Treatment with Altina might possibly increase the risk of skin cancer.
Tell your doctor if you or your family/caregiver notice that you are developing unusual behaviours that you cannot resist the impulse, urgent need, or craving to carry out certain activities that may be harmful to you or others. These are called impulse control disorders. In patients taking Altina and/or other medicines used to treat Parkinson's disease, such behaviours as compulsions, obsessive thoughts, pathological gambling, excessive spending, impulsive behaviour, and abnormally increased sexual drive or increased thoughts or feelings about sex have been observed. Your doctor may need to adjust or stop your dose (see section 4).
Altina may cause drowsiness and may cause you to fall asleep suddenly during daily activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson's disease). For further information, see the section “Driving and use of machines”.
Children and adolescents
The use of Altina in children and adolescents is not appropriate. Therefore, Altina is not recommended for patients under 18 years of age.
Other medicines and Altina
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Tell your doctor especially if you are taking any of the following medicines:
- Certain antidepressants (selective serotonin reuptake inhibitors, serotonin-noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants).
- The antibiotic ciprofloxacin used to treat infections.
- The cough suppressant dextromethorphan.
- Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and cold remedies containing ephedrine or pseudoephedrine.
The use of Altina together with antidepressants containing fluoxetine or fluvoxamine should be avoided.
If you are starting treatment with Altina, you must wait at least 5 weeks after stopping treatment with fluoxetine.
If you are starting treatment with fluoxetine or fluvoxamine, you must wait at least 14 days after stopping treatment with Altina.
Tell your doctor or pharmacist if you smoke or plan to stop smoking. Smoking may reduce the amount of Altina in your blood.
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.
You should avoid taking Altina if you are pregnant, as the effects of Altina on pregnancy and the fetus are unknown.
Driving and use of machines
Talk to your doctor before driving or operating machinery, as both Parkinson's disease and treatment with Altina may affect your ability to perform these activities. Altina may cause dizziness or drowsiness, as well as sudden episodes of falling asleep.
This risk may increase if you are taking other medicines to treat symptoms of Parkinson's disease, if you are taking medicines that may cause drowsiness, or if you consume alcohol during treatment with Altina. If you have experienced drowsiness and/or sudden sleep episodes before or during treatment with Altina, do not drive or operate machinery (see section 2).
3. How to take Altina
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose of Altina is 1 tablet of 1 mg taken orally, once daily.
Altina may be taken with or without food.
If you take more Altina than you should
If you think you have taken more rasagiline tablets than you should, inform your doctor or pharmacist immediately. Take the medicine package with you to show it to the doctor or pharmacist.
Symptoms reported following an overdose of rasagiline were slightly elevated mood (a mild form of mania), very high blood pressure, and serotonin syndrome (see section 4).
If you forget to take Altina
Do not take a double dose to make up for missed doses. Take the next dose as scheduled, at the usual time.
If you stop taking Altina
Do not stop treatment with this medicine without first consulting your doctor.
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 can cause adverse effects, although not everyone will experience them.
Contact your doctor immediately if you experience any of the following symptoms. You may require urgent medical treatment or intervention:
- If you experience unusual behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behaviour, abnormally increased sex drive, or increased sexual thoughts (impulse control disorders) (see section 2).
- If you see or hear things that are not real (hallucinations).
- Any combination of hallucinations, fever, restlessness, tremor, and sweating (serotonin syndrome).
Contact your doctor if you notice any suspicious changes in your skin, as there may be an increased risk of skin cancer (melanoma) with the use of this medicine (see section 2).
Other adverse effects
Very common (may affect more than 1 in 10 people)
- Involuntary movements (dyskinesia).
- Headache.
Common (may affect up to 1 in 10 people)
- Abdominal pain.
- Falls.
- Allergic reaction.
- Fever.
- Flu (influenza).
- General malaise.
- Neck pain.
- Chest pain (angina pectoris).
- Low blood pressure upon standing, with symptoms such as dizziness/lightheadedness (orthostatic hypotension).
- Decreased appetite.
- Constipation.
- Dry mouth.
- Nausea and vomiting.
- Flatulence.
- Changes in blood test results (leucopenia).
- Joint pain (arthralgia).
- Musculoskeletal pain.
- Joint inflammation (arthritis).
- Numbness and muscle weakness in the hand (carpal tunnel syndrome).
- Weight loss.
- Abnormal dreams.
- Difficulty with muscle coordination (balance disorder).
- Depression.
- Dizziness (vertigo).
- Prolonged muscle contractions (dystonia).
- Runny nose (rhinitis).
- Skin irritation (dermatitis).
- Rash.
- Redness of the eye (conjunctivitis).
- Urinary urgency.
Uncommon (may affect up to 1 in 100 people)
- Stroke (cerebrovascular accident).
- Heart attack (myocardial infarction).
- Blistering rash (vesiculobullous eruption).
Frequency not known: cannot be estimated from available data
- High blood pressure.
- Excessive sleepiness.
- Sudden sleep onset.
Reporting of adverse effects:
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Altina
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 or blister after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Altina
- The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as tartrate).
- The other components are: dibasic calcium phosphate dihydrate, corn starch, pregelatinized starch (from corn), anhydrous colloidal silica, talc, and stearic acid.
Appearance of the product and contents of the pack
Altina is presented as round, flat, white tablets.
The tablets are packaged in blisters made of Polyamide/Aluminum/PVC-Aluminum, in packs of 30 tablets.
Marketing Authorization Holder and Manufacturer
Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain
Date of the most recent revision of this leaflet: October 2023.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.