FRISTAMIN 10 mg Tabletka Powlekana
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Treść ulotki
Fristamin 10 mg tablets
Loratadine
Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor,
pharmacist or nurse has told you to.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If any of the undesirable effects occur, including effects not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
- If you do not improve or if your symptoms get worse, see your doctor. See section 4.
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, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Fristamin is and what it is used for
- 2. What you need to know before you take Fristamin
- 3. How to take Fristamin
- 4. Possible side effects
- 5. How to store Fristamin
- 6. Contents of the pack and other information
1. What Fristamin is and what it is used for
The full name of this medicine is Fristamin tablets
What is Fristamin
Fristamin tablets contains the active ingredient loratadine which belongs to a class of medicines
called “antihistamines”.
How Fristamin works
Fristamin helps to reduce allergic symptoms by blocking the effects of a substance called “histamine” which
is produced by the human body when you are allergic to something.
When to take Fristamin
Fristamin relieves the symptoms associated with allergic rhinitis (such as hay fever) such as: sneezing, runny nose and
itchy nose, burning and itchy eyes.
Fristamin is also used to relieve the symptoms of urticaria (itching, redness and number and
size of wheals).
The effect of Fristamin lasts a whole day and should help you to continue your normal daily activities
and to sleep.
See your doctor if you do not notice any improvement or if your symptoms worsen.
2. What you need to know before taking Fristamin
Do not take Fristamin if
- you are allergic (hypersensitive) to loratadine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Fristamin if:
- you suffer from liver disorders
- you are going to undergo skin tests for allergies. Do not take Fristamin in the two days before the tests, as this medicine may affect the results.
If any of the above points apply to you (or if you have any doubts), talk to your doctor, pharmacist or
nurse before taking Fristamin.
Children
Do not give Fristamin tablets to children under 6 years of age or to children with a weight equal to or
less than 30 kg. Other formulations more suitable are available for children under 6 years of age or with a weight equal to or less than 30 kg.
Children under 2 years of age
The safety and efficacy of Fristamin have not been established. No data are available.
Other medicines and Fristamin
The side effects of Fristamin may increase when taken together with medicines that
alter the function of certain enzymes responsible for drug metabolism in the liver.
However, in clinical studies, no increase in the side effects of loratadine was observed with
products that alter the function of these enzymes.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.
Fristamin and alcohol
It has not been shown that taking Fristamin with alcoholic beverages enhances its
effects.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor or
pharmacist for advice before taking this medicine.
As a precaution, it is preferable to avoid the use of Fristamin during pregnancy. Do not take
Fristamin if you are breastfeeding.
Loratadine is excreted in breast milk.
Driving and using machines
In clinical studies conducted to assess the ability to drive vehicles, no adverse effects were observed in
patients treated with loratadine .At the recommended dose, Fristamin is not expected to cause drowsiness or
reduced alertness. However, drowsiness has been very rarely reported in some
people, which may affect the ability to drive vehicles or use machines.
Fristamin contains lactose
Fristamin contains lactose; therefore, if your doctor has diagnosed you with intolerance to some sugars, contact
them before taking this medicine.
3. How to take Fristamin
Take this medicine following exactly the instructions in this leaflet or as instructed by your doctor, pharmacist or nurse. If you have any doubts, ask your doctor, pharmacist or nurse.
Take this medicine following exactly the instructions in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole.
What dose of Fristamin to take:
Adults and children over 6 years of age with a body weight greater than 30 kg:
Take one tablet once a day, with a glass of water, with or without food.
Body weight equal to or less than 30 kg:
Do not administer Fristamin. Other formulations are more suitable for children under 6 years of age or with a weight equal to or less than 30 kg.
Fristamin is not recommended for children under 2 years of age.
Adults and children with severe liver problems:
Adults and children weighing more than 30 kg:
Take one tablet every other day, with a glass of water, with or without food.
However, before taking this medicine you should consult your doctor, pharmacist or nurse.
If you take more Fristamin than you should
If you take more Fristamin than you should, seek immediate medical or pharmaceutical advice.
Serious problems should not arise, but headache, rapid heartbeat or drowsiness may occur.
If you forget to take Fristamin
- If you forget to take the medicine, take it as soon as you remember, then continue treatment as usual.
- Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported side effects in adults and children over 12 years of age are:
- drowsiness
- headache
- increased appetite
- difficulty sleeping.
The most commonly reported side effects in children between 2 and 12 years of age are:
- headache
- nervousness
- fatigue
The following side effects very rare(may affect up to 1 in 10,000 people) have also been
observed during the marketing of loratadine:
- severe allergic reaction (including swelling)
- dizziness
- convulsions
- fast or irregular heartbeat
- nausea (feeling sick)
- dry mouth
- stomach discomfort
- liver problems
- hair loss
- skin rash
- fatigue Frequency not known:
- Weight gain
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor, pharmacist or nurse .You can also report side effects directly through
the national reporting system at 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 Fristamin
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date that is reported on the blister after Scad.. The date of
expiry refers to the last day of that month.
Do not use this medicine if you notice changes in the appearance of the tablet.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Fristamin contains
- The active ingredient is loratadine. Each tablet contains 10 mg of loratadine.
- The other ingredients are lactose monohydrate, corn starch and magnesium stearate.
Description of the appearance of Fristamin and contents of the pack
Tablet.
Ovale tablet of colour from white to almost white, with imprinted on one side a flask and a mortar, a
score line and the number “10”.
Fristamin tablets is available in packs of 2, 5, 7, 10, 14, 15, 20, 21, 28, 30, 50, 60 or 100
tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
F.I.R.M.A. S.p.A. - Via di Scandicci, 37 - Florence
Manufacturer:
Schering-Plough Labo NV, Industriepark 30, B-2220 Heist-op-den-Berg, Belgium
Schering-Plough – Rue Louis Pasteur 2 – F-14200 Herouville Saint Clair - France
This medicinal product is authorised in the Member States of the European Economic Area with the following
names
Italy: Fristamin
Belgium, Luxembourg: Loratadine SP
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- Kraj rejestracji
- Postać farmaceutycznaCoated tablet, 10 MG
- Kod ATCR06AX13
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki FRISTAMINPostać farmaceutyczna: Tablet, 10 MGSubstancja czynna: loratadineProducent: BAYER S.P.A.Wymaga receptyPostać farmaceutyczna: Coated tablet, 10 MGSubstancja czynna: loratadineProducent: TEVA ITALIA S.R.L.Wymaga receptyPostać farmaceutyczna: Film-coated tablet, 5 MGSubstancja czynna: desloratadineProducent: N.V. ORGANONWymaga recepty
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FRISTAMIN wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w FRISTAMIN jest loratadine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
FRISTAMIN jest produkowany przez F.I.R.M.A. S.P.A.. 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 FRISTAMIN 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 FRISTAMIN w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (loratadine) to m.in. KLARITYN, LORATADINA TEVA, AERIUS. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
