ECUMENS

Package leaflet: Information for the patient

Ecumens 1200 mg powder for oral solution, 3 g powder for oral solution

Piracetam
Generic medicine
Please read all of this leaflet carefully before 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Ecumens is and what it is used for
2. What you need to know before taking Ecumens
3. How to take Ecumens
4. Possible side effects
5. How to store Ecumens
6. Contents of the pack and other information

1. What Ecumens is and what it is used for

Ecumens contains the active substance piracetam, which belongs to a group of medicines known as
psychostimulant and nootropic drugs, which work by improving oxygen supply to the brain or
by stimulating the nervous system.
Ecumens, used alone (monotherapy) or in combination with other medicines, is indicated for the treatment of
movement disorder caused by brain problems and characterised by brief and sudden muscle contractions (cortical myoclonus), a condition in which muscles, especially in the arms and legs, begin to jerk uncontrollably.
If you do not feel better or if you feel worse, please consult your doctor.

2. What you need to know before taking Ecumens

Do not take Ecumens

• if you are allergic to piracetam or to any of the other ingredients of this medicine (listed in section 6);
• if you have had episodes of cerebral haemorrhage;
• if you suffer from severe kidney disease, especially if in the terminal stage;
• if you have Huntington's disease (also known as Huntington's chorea). If any of these conditions apply to you, do not take Ecumens and contact your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ecumens if:

• you have recently had problems with blood clotting;
• you have had a problem with the blood vessels in your brain (cerebrovascular accident);
• you have a stomach or intestinal ulcer;
• you are due to undergo surgery or dental treatment;
• your kidneys do not function properly (your doctor may need to start treatment with a lower dose);
• you are taking medicines to reduce blood clotting (anticoagulants or antiplatelet agents, including low-dose aspirin);
• you are elderly and undergoing long-term treatment. Your doctor will monitor you to determine the appropriate dose.

Other medicines and Ecumens
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may alter the effect of Ecumens, or the effect of these medicines may be altered by Ecumens. This type of interaction may reduce the effect of one or both medicines. Alternatively, it may increase the risk or severity of side effects.
Inform your doctor if you are taking any of the following medicines:

• thyroid extracts (T3 and T4) or thyroxine;
• acenocoumarol;
• low-dose aspirin;
• carbamazepine, phenytoin, phenobarbital, valproate (medicines used to treat epilepsy).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Ecumens if you are pregnant. If use is necessary, consult your doctor, who will assess whether the potential benefits outweigh the possible risks to you and your baby.
Breastfeeding
Piracetam is excreted in breast milk.
If necessary, inform your doctor, who will assess whether the benefits of piracetam therapy outweigh the risks to the infant. Your doctor will decide whether to discontinue breastfeeding or to discontinue piracetam therapy.

Driving and using machines
Ecumens may impair your ability to drive or use machinery. Do not drive or operate machinery until you know how this medicine affects your ability to perform these activities.

3. How to take Ecumens

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is 7.2 g per day, divided into two or three doses, which may be
increased by 4.8 g every three or four days.
The maximum dose is 24 g of piracetam.
When starting this medicine, your doctor may instruct you to gradually increase the dose to ensure
that you are receiving the amount of medicine needed to treat your condition.
Once started, treatment with Ecumens should be continued for as long as the original disorder persists.
Follow your doctor's instructions carefully.

Use in the elderly and in patients with kidney problems
If you are elderly or have kidney problems, the dose should be reduced. Ask your doctor for advice,
who will determine the most appropriate dose for you.

Instructions for use

Ecumens must be administered orally and may be taken with or without food.

Pour the dose into the dosing cup and add water as follows:

Shake to dissolve the powder and drink the solution.
After use, wash the dosing cup with water.
If you take more Ecumens than you should
If you have accidentally taken an excessive amount of piracetam, contact your doctor and go immediately to the nearest hospital. Remember to take the Ecumens pack with you.
If you forget to take Ecumens
Do not take a double dose to make up for the forgotten dose.
If you stop taking Ecumens
Do not stop treatment with Ecumens without first consulting your doctor. Abrupt discontinuation of Ecumens may cause muscle contractions and twitches.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects generally disappear after a few weeks of treatment. Please bear in mind that many of the side effects may also be symptoms of your underlying illness, and therefore will diminish as you start feeling better.
If any of the following conditions occur during treatment, stop taking the medicine immediately
and contact your doctor or go to the nearest hospital without delay

• severe, sudden-onset allergic reaction causing skin rash, difficulty breathing, fainting, or swelling of the face and throat (anaphylactic reactions);
• severe and sudden swelling of the skin or mucous membranes, for example swelling around the eyes, face, lips, mouth, or throat (angioedema);
• increased frequency of epileptic seizures (worsening epilepsy), hypersensitivity.

In addition, the following side effects have been reported, some of which occurred only after parenteral administration of piracetam; therefore, they refer to medicines containing the same active substance as Ecumens but with different pharmaceutical forms and routes of administration:
Rare (may affect up to 1 in 1,000 people):

• inflammation of superficial veins leading to thrombosis (thrombophlebitis) (only with injectable form), low blood pressure (only with injectable form);
• pain at injection site (only with injectable form), fever (only with injectable form).

Uncommon (may affect up to 1 in 100 people):

• depression;
• drowsiness;
• fatigue.

Common (may affect up to 1 in 10 people):

• nervousness;
• hyperactivity;
• weight gain.

Not known (frequency cannot be estimated from the available data):

• bleeding (haemorrhage);
• allergy;
• agitation, anxiety, confusion, hallucinations;
• loss of muscular coordination (ataxia), impaired balance, headache, insomnia;
• increased frequency of epileptic seizures (worsening epilepsy);
• dizziness;
• abdominal pain, upper abdominal pain, diarrhoea, nausea, vomiting;
• swelling of the skin, mucous membranes, and submucosal tissues (angioedema), skin rash, itching, urticaria.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ecumens

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box or sachet after the word "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ecumens contains
The active substance is piracetam.
Each sachet of Ecumens 1200 mg oral solution powder contains 1200 mg of piracetam.
Each sachet of Ecumens 3 g oral solution powder contains 3 g of piracetam.
The other components are: vanillin flavor, sucralose.

Description of the appearance of Ecumens and the contents of the pack
Oral solution powder.
Ecumens 1200 mg oral solution powder is available in a pack containing 40 sachets made of paper/polyethylene/aluminum/polyethylene and a dosing cup made of polypropylene.
Ecumens 3 g oral solution powder is available in a pack containing 12 sachets made of paper/polyethylene/aluminum/polyethylene and a dosing cup made of polypropylene.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ecupharma S.r.l.
Via Mazzini 20
20123 Milano
Italy

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)
Italy