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ANACERVIX 20 mg/400 mg HARD CAPSULES

Ask a doctor about a prescription for ANACERVIX 20 mg/400 mg HARD CAPSULES

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use ANACERVIX 20 mg/400 mg HARD CAPSULES

Introduction

Patient Information Leaflet

Anacervix 20 mg/400 mg hard capsules

Vincamine/Piracetam

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

  • Keep this leaflet, as you may need to read it again.
  • If you have any doubts, consult your doctor or pharmacist.
  • This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

  1. What Anacervix is and what it is used for
  2. What you need to know before taking Anacervix
  3. How to take Anacervix
  4. Possible side effects
  5. Storage of Anacervix
  6. Package contents and additional information

1. What Anacervix is and what it is used for

Anacervix belongs to the group of medicines called peripheral vasodilators (medicines that improve blood flow).

It is indicated for the symptomatic treatment of mild cognitive impairment associated with age.

2. What you need to know before taking Anacervix

Do not takeAnacervix

  • If you are allergic to vincamine or piracetam, or to any of the other components of this medicine (listed in section 6).
  • If you have severe renal (kidney) or hepatic (liver) insufficiency.
  • If you have increased intracranial pressure (high pressure in the skull).
  • If you have severe arterial hypertension.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Anacervix, especially:

Taking Anacervix with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicines.

Anacervix may enhance the effect of antihypertensives (medicines for high blood pressure) and those that decrease heart rate, such as beta-blockers and digitalis.

The 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 some antiepileptics (used to prevent seizures) and barbiturics (drugs that cause relaxation and drowsiness).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There are no data on the use of the vincamine-piracetam combination in pregnant women, so it is not recommended to take this medicine during pregnancy.

There is not enough information on the passage of vincamine and piracetam into breast milk. Breastfeeding should be interrupted during treatment with Anacervix.

Driving and using machines

Do not drive or operate tools or machines during the first few days of treatment, as Anacervix may affect your ability to drive and use machines.

3. How to take Anacervix

Follow the administration instructions for this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 capsule 3 times a day, as determined by your doctor. The capsules should be taken preferably after the main meals.

If you take moreAnacervixthan you should

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

The most frequent symptoms are muscle weakness, marked low 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 poisoning.

If you forget to takeAnacervix

Do not take a double dose to make up for forgotten doses.

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The following side effects have been described (frequency unknown):

Nervous system disorders

Hypersomnia (excessive sleeping without apparent cause), insomnia, somnolence, nervousness, tremor, dizziness.

Gastrointestinal disorders

Abdominal distension (swollen abdomen), nausea, abdominal pain, gastralgia (stomach pain).

Vascular disorders

Hypotension (low blood pressure).

Skin and subcutaneous tissue disorders

Rubelliform rash (skin eruption or rash).

Renal and urinary disorders

Dysuria (difficulty and discomfort when urinating).

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es.

By reporting side 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 expiration date stated on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition ofAnacervix

  • The active ingredients are vincamine and piracetam. Each capsule contains 20 mg of vincamine and 400 mg of piracetam.
  • The other ingredients are cornstarch, magnesium stearate, and talc. The capsule shell is made of hard gelatin.

Appearance of the product and package contents

Anacervix is a medicine that comes in hard gelatin capsules with a white body and gray cap. It is available in boxes of 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-Australia Building

08840 Viladecans, Barcelona (Spain)

Manufacturer

Alcalá Farma, S.L.

Avenida de Madrid 82

28802 Alcalá de Henares

Madrid - Spain

Date of the last revision of this leaflet:July 2014

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es.

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