DIZZITAM 200 mg /Ml Roztwór Doustny
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Treść ulotki
DIZZITAM 200 mg/ml oral and injectable solution for intravenous use
Piracetam
Generic medicine
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What DIZZITAM is and what it is used for
- 2. What you need to know before you use DIZZITAM
- 3. How to take DIZZITAM
- 4. Possible side effects
- 5. How to store DIZZITAM
- 6. Contents of the pack and other information
1. What is DIZZITAM and what it is used for
DIZZITAM contains the active ingredient piracetam which belongs to a group of medicines known as psychostimulants and nootropics, which work by improving oxygen supply to the brain or stimulating the nervous system.
DIZZITAM alone (monotherapy) or in combination with other medicines is indicated in the treatment of movement disorder caused by problems with the brain and characterized by brief and sudden muscle contractions (cortical myoclonus) which is a condition in which the muscles, especially of the arms and legs, begin to contract jerkily and uncontrollably.
See your doctor if you do not feel better or if you feel worse.
2. What you need to know before using DIZZITAM
Do not use DIZZITAM
- If you are allergic to piracetam, or to other pyrrolidone derivatives, or to any of the other ingredients of this medicine (listed in section 6);
- If you have cerebral haemorrhage;
- If you have end-stage renal disease;
- If you suffer from Huntington's chorea (a neurodegenerative genetic disease).
Warnings and precautions
Talk to your doctor or pharmacist before using DIZZITAM.
In particular:
If you have or have had a severe haemorrhage, if you are at risk of bleeding such as in cases of gastrointestinal ulcer, if you have blood coagulation disorders (haemostasis), if you have had a problem with the blood vessels of the brain (haemorrhagic stroke), if you are undergoing major surgery, including dental surgery, if you are taking medicines to reduce blood clotting (anticoagulants or antiplatelet agents, including low-dose aspirin).
This is because piracetam has effects on platelet aggregation.
If you suffer from renal insufficiency, as piracetam is eliminated via the kidneys (see
section: “How to use DIZZITAM”)
If you are an elderly patient, as, in the case of long-term treatment, it may be
necessary to monitor creatinine clearance to allow your doctor to assess, if
necessary, a dose adjustment (see section: “How to use DIZZITAM”).
If you suffer from myoclonus (brief and sudden involuntary muscle contraction), you should avoid
abrupt discontinuation of treatment as it may induce a sudden relapse or withdrawal crisis.
Other medicines and DIZZITAM
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Interactions of piracetam with other medicines are unlikely.
The use of piracetam does not modify the activity of other antiepileptic drugs (carbamazepine, phenytoin,
phenobarbital, valproate).
You should be cautious if you are taking:
- Thyroid hormones (thyroid extracts (T3 + T4)) in combination with piracetam, as you may experience confusion, irritability and sleep disturbances.
- Acenocoumarol; piracetam may reduce its effectiveness.
- Medicines to reduce blood clotting (anticoagulants, antiplatelet agents, including low-dose aspirin); concomitant use may involve an increased risk of bleeding.
DIZZITAM with alcohol
Concomitant administration of alcohol has not affected the levels of piracetam in the blood and
alcohol levels have not been modified by an oral dose of 1.6 g of piracetam.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Piracetam crosses the placental barrier, therefore it should not be used during pregnancy unless your
doctor tells you it is clearly necessary.
Breastfeeding
Piracetam is excreted in breast milk and therefore, during breastfeeding, you should avoid treatment
with this medicine or you should discontinue breastfeeding.
The decision to discontinue breastfeeding or stop therapy with piracetam should be made by
your doctor, who will consider the benefits of breastfeeding for the baby and the benefits of
therapy with piracetam for you.
Driving and using machines
Piracetam may impair the ability to drive or operate machinery.
DIZZITAM contains sodium(as Sodium acetate trihydrate)
This medicine contains less than 1 mmol (23 mg) of sodium per 24 g of piracetam, i.e. essentially
‘sodium-free’.
3. How to take DIZZITAM
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended initial dose is 7.2 g per day, divided into two or three administrations, which may be increased by 4.8 g every three or four days up to a maximum of 24 g.
Once started, treatment with piracetam must be continued as long as the original disorder persists.
If you are taking other anti-myoclonic medications, your doctor will tell you to maintain the same dosage. The doctor may reduce the dosage following the assessment of the clinical benefit obtained.
If you experience an acute episode, contact your doctor who will assess whether to decrease or discontinue treatment.
Elderly
If you are an elderly patient and suffer from kidney problems, your doctor will adjust the dosage. In the case of long-term treatment, your doctor will regularly evaluate your kidney function values and, if necessary, will assess a dosage adjustment.
Patients with renal insufficiency
Your doctor will adjust the daily dose according to your kidney function.
Patients with hepatic insufficiency
If you suffer only from hepatic insufficiency, you do not need to adjust the dosage. If, however, you suffer from both renal and hepatic insufficiency, your doctor will adjust the dose.
Method of administration
Take this medicine orally.
You can take DIZZITAM with or without food.
Take the daily dose of DIZZITAM dividing it into equal parts to be taken 2 to 4 times a day.
If parenteral administration is necessary (for example in case of difficulty swallowing, state of unconsciousness), you can take DIZZITAM intravenously at the same recommended daily dose.
The injectable solution in vials must be administered intravenously via injection lasting several minutes.
To open, hold the vial vertically ensuring that the colored point is in the position indicated in the figure.
Apply pressure with your thumb placed above the colored point as shown in the figure
If you use more DIZZITAM than you should
In case of accidental ingestion/intake of an excessive dose of DIZZITAM, immediately inform your doctor or go to the nearest hospital.
If you forget to use DIZZITAM
If you forget to take DIZZITAM, take it as soon as you remember, then continue as usual.
Do not take a double dose to make up for a missed dose.
If you stop taking DIZZITAM
If you have any 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 everybody gets them.
Common side effects (may affect up to 1 in 10 people):
- nervousness
- hyperactivity
- weight gain
Uncommon (may affect up to 1 in 100 people)
- depression
- drowsiness
- fatigue
Rare (may affect up to 1 in 1,000 people)
- inflammation of superficial veins with resulting thrombosis (thrombophlebitis, only for the injectable form), low blood pressure (hypotension, only for the injectable form)
- pain at the injection site (only for the injectable form), pyrexia (only for the injectable form)
Not known (frequency cannot be estimated from the available data):
- bleeding disorder
- anaphylactoid reaction, hypersensitivity
- agitation, anxiety, confusion, hallucinations
- loss of muscle coordination (ataxia), impaired balance, increased seizures (aggravated epilepsy), headache, insomnia
- dizziness
- abdominal pain, upper abdominal pain, diarrhea, nausea, vomiting
- swelling of the skin, mucous membranes and submucosal tissues (angioedema), dermatitis, pruritus, urticaria
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
http://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 DIZZITAM
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions. Do not freeze
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What DIZZITAM contains
- The active ingredient is piracetam. 1 vial of 10 ml contains 2 g of piracetam. 1 vial of 5 ml contains 1 g of piracetam
- The other ingredients are: Sodium acetate trihydrate, Glacial acetic acid, Water for injections
Description of the appearance of DIZZITAM and contents of the pack
Oral and injectable solution for intravenous use. Vials of 5 and 10 ml. Pack of 10 vials.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Farma Group SRL
Via N. Strampelli, 18
63074, San Benedetto del Tronto (AP )
Italy
Manufacturer
AS KALCEKS.
Krustpils iela 71E,
Rīga, LV-1057,
Latvia.
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- Kraj rejestracji
- Postać farmaceutycznaOral solution, 200 MG/ML
- Kod ATCN06BX03
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki DITSTSITAMPostać farmaceutyczna: Oral solution powder, 1200 MGSubstancja czynna: piracetamProducent: ECUPHARMA S.R.L.Wymaga receptyPostać farmaceutyczna: Film-coated tablet, 1200 MGSubstancja czynna: piracetamProducent: ADVANZ PHARMA LIMITEDWymaga receptyPostać farmaceutyczna: Injectable solution, 250 MGSubstancja czynna: citicolineProducent: S.F. GROUP S.R.L.Wymaga recepty
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DITSTSITAM wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w DITSTSITAM jest piracetam. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
DITSTSITAM jest produkowany przez FARMA GROUP S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie DITSTSITAM jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić DITSTSITAM w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
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Inne leki zawierające tę samą substancję czynną (piracetam) to m.in. EKUMENS, NOOTROPIL, KIDILIN. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
