Package Insert: Information for the Patient

Anacervix 20 mg/400 mg Hard Capsules

Vincamina/Piracetam

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isAnacervixand for what it is used

2. What you need to know before starting to takeAnacervix

3. How to takeAnacervix

4. Possible adverse effects

5. Storage ofAnacervix

6. Contents of the package and additional information

Anacervix belongs to a group of medications known as peripheral vasodilators (medications that improve blood flow).

It is indicated for the symptomatic treatment of mild cognitive decline associated with aging.

Do not take Anacervix

• If you are allergic to vincamina or piracetam, or to any of the other components of this medication (listed in section 6).
• If you have severe renal (kidney) or hepatic (liver) insufficiency.
• If you have hypertensive encephalopathy (increased intracranial pressure).
• If you suffer from severe 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), your doctor may reduce your dose.
• If you have high blood pressure, heart failure, coronary artery disease, are at risk of or have had a myocardial infarction.

Taking Anacervix with other medications

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

Anacervix may potentiate the action of antihypertensives (medications for treating high blood pressure) and those medications that decrease heart rate, such as beta-blockers and digitals.

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 barbiturates (medications that cause relaxation and drowsiness).

Pregnancy and breastfeeding

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

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

There is insufficient information on the passage of vincamina and piracetam into breast milk. Breastfeeding should be discontinued during treatment with Anacervix.

Driving and operating machinery

Do not drive or operate tools or machinery during the first few days of treatment, as Anacervix may have some influence on your ability to drive and operate machinery.

Follow exactly the administration instructions for this medication 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. Capsules should be taken preferably 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The most frequent symptoms are muscle weakness, marked blood pressure drop, 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 forgot to take Anacervix

Do not take a double dose to compensate for the missed doses.

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

Like all medications,this medicationcan produce adverse effects, although not all people experience them.The following adverse effects have been described (unknown frequency):

Nervous System Disorders

Hypersomnia (excessive sleep without apparent cause), insomnia, drowsiness, 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

Rubella-like rash (skin eruption or rash).

Renal and Urinary Disorders

Disuria (difficulty and discomfort urinating).

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://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 use this medication after the expiration date that appears on the packaging after the abbreviation 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 the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofAnacervix

• The active principles are vincamina and piracetam. Each capsule contains 20 mg of vincamina and 400 mg of piracetam.

• The other components are cornstarch, magnesium stearate, and talc. The capsule coating is made of hard gelatin.

Appearance of the product and contents of the packaging

Anacervixis a medication that is presented in hard gelatin capsules with a white body and a grey cap.It is presented in boxes of 30 or 60 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Edificio Australia

08840 Viladecans, Barcelona (Spain)

Responsible for manufacturing

Alcalá Farma, S.L.

Avenida de Madrid 82

28802 Alcalá de Henares

Madrid - Spain

Last review date of this leaflet:July 2014

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