Anacervix 20 mg/400 mg hard capsules
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Anacervix 20 mg/400 mg hard capsules
Vincamine/Piracetam
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Anacervix is and what it is used for
- What you need to know before taking Anacervix
- How to take Anacervix
- Possible adverse effects
- How to store Anacervix
- Contents of the pack and other information
1. What Anacervix is and what it is used for
Anacervix belongs to a group of medicines called peripheral vasodilators (medicines that improve blood flow).
It is indicated for the symptomatic treatment of mild age-associated cognitive decline.
2. What you need to know before starting to take Anacervix
Do not take Anacervix
- If you are allergic to vinpocetine or piracetam, or to any of the other ingredients of this medicine (listed in section 6).
- If you have severe renal (kidney) or hepatic (liver) insufficiency.
- If you have intracranial hypertension (increased pressure inside the skull).
- If you suffer from severe arterial hypertension.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Anacervix, especially:
- if you have liver or kidney problems (hepatic or renal insufficiency); in this case, your doctor may reduce your dose.
- if you suffer from high blood pressure, heart failure (inadequate pumping of blood), coronary artery disease, or are at risk of, or have had, a myocardial infarction.
Taking Anacervix with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Anacervix may enhance the effects of antihypertensive drugs (medications used to treat high blood pressure) and of drugs that reduce heart rate, such as beta-blockers and cardiac glycosides.
Concomitant administration of piracetam and oral anticoagulants may increase prothrombin time (the time it takes for blood to clot).
Anacervix may increase or decrease the effects of certain antiepileptic drugs (used to prevent seizures) and barbiturates (drugs that cause relaxation and drowsiness).
Pregnancy and breastfeeding
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.
There are no data available on the use of the vinpocetine-piracetam combination in pregnant women, therefore this medicine is not recommended during pregnancy.
There is insufficient information regarding the passage of vinpocetine and piracetam into breast milk. Breastfeeding should be discontinued during treatment with Anacervix.
Driving and using machines
Do not drive or operate tools or machinery during the first few days of treatment, as Anacervix may affect your ability to drive and use machines.
3. How to take Anacervix
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is 1 capsule three times a day, according to medical judgment. Capsules should preferably be taken after main meals.
If you take more Anacervix than you should
In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
The most frequent symptoms are muscle weakness, marked drop in blood pressure, excitement, anxiety, or insomnia. Your doctor will advise you on any additional measures that may be necessary, depending on the severity of the intoxication.
If you forget to take Anacervix
Do not take a double dose to make up for forgotten doses.
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 cause adverse effects, although not everyone will experience them. The following adverse effects have been reported (frequency unknown):
Nervous system disorders
Hypersomnia (excessive sleep without apparent cause), insomnia, somnolence, nervousness, tremor, dizziness.
Gastrointestinal disorders
Abdominal distension (swollen abdomen), nausea, abdominal pain, gastralgia (stomach ache).
Vascular disorders
Hypotension (low blood pressure).
Skin and subcutaneous tissue disorders
Rubella-like rash (skin eruption or rash).
Renal and urinary disorders
Dysuria (difficulty and discomfort when urinating).
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 Medicinal Products: https://www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Anacervix
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation 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 the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Anacervix
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The active substances are vincamine and piracetam. Each capsule contains 20 mg of vincamine and 400 mg of piracetam.
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The other components are corn starch, magnesium stearate, and talc. The capsule shell is made of hard gelatin.
Appearance of the product and contents of the container
Anacervix is a medicine presented as hard gelatin capsules with a white body and grey cap. It is available in boxes containing 30 or 60 capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ANGELINI PHARMA ESPAÑA, S.L.
c/ Antonio Machado, 78-80
3rd floor, module A-Building Australia
08840 Viladecans, Barcelona (Spain)
Manufacturer
Alcalá Farma, S.L.
Avenida de Madrid 82
28802 Alcalá de Henares
Madrid - Spain
Date of the most recent revision of this leaflet: July 2014
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