Nootropil

Patient Information Leaflet

Nootropil 1200 mg film-coated tablets

piracetam
Please read 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Nootropil is and what it is used for

Nootropil contains the active substance piracetam and belongs to a group of medicines known as GABA analogues, substances that inhibit neuronal activity in the brain.
Nootropil is used alone (monotherapy) or in combination with other medicines in the treatment of movement disorder caused by brain problems and characterised by brief and sudden muscle contractions (cortical myoclonus), a condition in which muscles, particularly in the arms and legs, begin to contract abruptly and uncontrollably.

2. What you should know before taking Nootropil

Do not take Nootropil

• if you are allergic to piracetam, to other pyrrolidone derivatives, or to any of the other ingredients of this medicine listed in section 6
• if you have had cerebral haemorrhage
• if you have severe kidney problems
• if you have Huntington's disease (also known as Huntington's chorea).

Warnings and precautions
Talk to your doctor or pharmacist before taking Nootropil.
It is particularly important that you speak to your doctor or pharmacist before taking Nootropil 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 acetylsalicylic acid)
• you are an elderly patient undergoing long-term treatment. Your doctor will monitor you to determine the appropriate dose.

Other medicines and Nootropil
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important that you inform your doctor if you are taking:

• thyroid extracts or thyroxine
• anticoagulants or medicines that inhibit platelet function, such as acenocoumarol or acetylsalicylic acid, even at low doses
• medicines used to treat epilepsy (carbamazepine, phenytoin, phenobarbital, valproate)
• alcohol.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Nootropil during pregnancy. If its use is strictly necessary, consult your doctor, who will assess whether the potential benefits outweigh the possible risks for you and your baby.
Breastfeeding
Nootropil is excreted in breast milk. Therefore, treatment with this medicine should either be avoided or breastfeeding discontinued. If treatment is necessary, inform your doctor, who will evaluate whether the benefits of piracetam therapy outweigh the risks to the infant. Your doctor will decide whether to discontinue breastfeeding or stop treatment with Nootropil.
Driving and using machines
Nootropil may affect 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.
Nootropil contains sodium
This medicine contains 46 mg of sodium (a key component of table salt) per 24 g of piracetam. This corresponds to 2.3% of the maximum daily recommended dietary intake for an adult. This should be taken into account if you are on a low-sodium diet.

3. How to take Nootropil

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Adults
The recommended starting dose is 7.2 g (six tablets) per day. This dose should be divided into two daily administrations, i.e. three tablets in the morning and three tablets in the evening, or into three daily doses, depending on your doctor's instructions.

Your doctor may advise you to gradually increase the dose every three or four days until reaching the correct individual dose for you. The maximum daily dose is 24 g of piracetam (twenty tablets).

Always follow your doctor's instructions carefully.

Elderly patients and patients with renal problems
If you are 65 years of age or older, or if you have kidney problems, your doctor may prescribe a lower dose.

Your doctor will monitor your kidney function to ensure you are taking the most appropriate dose of Nootropil.

How to take the medicine
The tablets may be taken with or without food.

Swallow the tablets whole with a glass of water.

Do not break or chew the tablets.

If you take more Nootropil than you should
If you accidentally take too many tablets, contact your doctor or go immediately to the nearest emergency room for assistance. Inform them that you are taking Nootropil.

If you forget to take Nootropil
Do not take a double dose to make up for the missed dose.
Simply take the next dose as scheduled.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

If you stop taking Nootropil
Do not stop taking Nootropil without first talking to your doctor. In some cases, your doctor may advise you to discontinue treatment with this medicine. This should be done by reducing the dose every two or three days. Abruptly stopping treatment may cause symptoms to reappear or worsen.

If you have any questions 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 everyone experiences them.
If any of the following conditions occur during treatment, stop taking the medicine and contact your doctor immediately, or go to the nearest hospital (frequency cannot be determined from available data):

• a severe and sudden allergic reaction with breathing difficulties, sweating, fever, skin rash, fainting, or swelling of the face and throat (anaphylactic reaction, hypersensitivity);
• severe and sudden swelling of the skin or mucous membranes, for example swelling around the eyes, face, lips, mouth, or throat (angioedema);
• increase in epileptic seizures (worsening epilepsy).

You may experience the following side effects:

Common: may affect from 1 to 10 people in 100

• nervousness
• abnormally increased muscle activity or function (hyperkinesia)
• weight gain

Uncommon: may affect from 1 to 10 people in 1,000

• depression
• drowsiness
• feeling weak (asthenia)

Not known: frequency cannot be determined from available data

• spontaneous bleeding due to defects in the blood coagulation mechanism (bleeding disorder)
• anxiety
• agitation
• confusion
• hallucinations
• disturbance of balance, lack of muscular coordination (ataxia)
• headache
• insomnia
• dizziness
• abdominal pain
• upper abdominal pain
• diarrhoea
• nausea
• vomiting
• dermatitis
• pruritus
• urticaria

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nootropil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp.
The expiry date refers to the last day of the month.
Do not dispose of any medicine 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 Nootropil contains

• The active substance is piracetam. Each tablet contains 1200 mg of piracetam.
• The other components are:

Tablet core: Macrogol 6000, Anhydrous colloidal silica, Magnesium stearate, Sodium croscarmellose.
Tablet coating: Opadry Y-1-7000, composed of: Hypromellose, Titanium dioxide, Polyethylene glycol 400; Opadry OY-S-29019, composed of: Hypromellose and Macrogol 6000.
Description of the appearance of Nootropil and package contents
Each pack contains 40 film-coated tablets in blisters with a break line and marked N/N.
Marketing Authorization Holder
Advanz Pharma Limited
Unit 17, Northwood House,
Northwood Crescent,
Dublin 9,
D09 V504,
Ireland
Manufacturer
UCB Pharma SA – Chemin du Foriest – 1420 Braine l’Alleud (BELGIUM).
or
Aesica Pharmaceuticals S.r.l. – Via Praglia 15 – 10044 Pianezza (TO).
or
Aesica Pharmaceuticals GmbH - Alfred-Nobel-Str. 10 - 40789 Monheim am Rhein (GERMANY).