DESMOPRESSINA 60 MICROGRAMS Tabletka sublingwalna
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Treść ulotki
Desmopressina Teva 60 micrograms sublingual tablets, 120 micrograms sublingual tablets
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 their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Desmopressina Teva is and what it is used for
- 2. What you need to know before you take Desmopressina Teva
- 3. How to take Desmopressina Teva
- 4. Possible side effects
- 5. How to store Desmopressina Teva
- 6. Contents of the pack and other information
1. What is Desmopressina Teva and what is it used for
Desmopressin, the active ingredient contained in Desmopressina Teva, acts like the natural hormone
vasopressin and regulates the kidneys’ ability to concentrate urine.
Desmopressina Teva is used to treat:
- Central diabetes insipidus (a pituitary gland disorder that causes severe thirst and the excretion of a large amount of urine, usually pale in color and similar to water).
- Nocturnal enuresis in children starting from 5 years of age with normal urine concentrating ability (a condition consisting of involuntary urination during sleep).
- Nocturia in adults under 65 years of age (a condition in which you frequently wake up during the night to urinate).
2. What you need to know before taking Desmopressina Teva
Do not take Desmopressina Teva:
- if you are allergic to desmopressin or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from polydipsia (abnormal intake of large quantities of fluids), heart failure and other conditions that require treatment with diuretics;
- if you have moderate or severe impaired kidney function;
- if you have low levels of sodium in the blood;
- if you are unable to comply with fluid restriction;
- if you have a disorder of hormone secretion (so-called SIADH);
- if you are over 65 years of age and suffer from nocturia (see section 1);
- if your child is under 5 years of age and suffers from nocturnal enuresis (see section 1).
Warnings and precautions
For the management of nocturnal enuresis (involuntary urination during the night) in children, lifestyle interventions and the use of a night alarm (a device that
emits a sound or vibration when urine is lost) are initially used.
If these measures are not effective or if drug therapy is necessary, treatment with
desmopressin can be started.
Talk to your doctor before using Desmopressina Teva:
- if you have coronary heart disease (affecting the blood vessels that supply the heart) or high blood pressure;
- if you have a thyroid (a gland located in the neck) or adrenal (a gland located above the kidney) disease;
- if you develop a disease during treatment that causes fever, vomiting or diarrhea;
- if you experience headache, loss of appetite, nausea, vomiting, weight gain, confusion (difficulty understanding words, difficulty concentrating) or convulsions (violent and involuntary contractions of one or more limbs) during treatment; these symptoms may be signs of a dangerous condition called hyponatremia (low sodium levels in the blood);
- for the treatment of central diabetes insipidus: it is necessary to decrease water consumption and consult a doctor immediately. The doctor will reduce the doses or suspend treatment for a few hours;
- for the treatment of nocturnal enuresis or nocturia: treatment should be discontinued, water consumption reduced and a doctor consulted immediately;
- if you are at risk of increased pressure inside the skull.
When treating nocturnal enuresis and nocturia, during the period between 1 hour before and 8 hours after
taking this medicine, fluid intake should be reduced to the minimum necessary to
manage thirst.
Desmopressina Teva should be used with caution in patients with fluid balance disorders. Consult
your doctor if, in association with an acute illness, you experience fluid and/or
electrolyte balance disorders.
Children
In children, this medicine should be used under the supervision of an adult.
Do not give this medicine to children under 5 years of age.
Other medicines and Desmopressina Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
The effect of Desmopressina Teva may be increased, with a greater risk of accumulation of an
abnormal amount of fluid in the body, if it is taken at the same time as some medicines
used to treat:
- depression (such as tricyclic antidepressants, selective serotonin reuptake inhibitors);
- psychosis (such as chlorpromazine);
- epilepsy (such as carbamazepine);
- diabetes (so-called sulfonylureas, e.g. chlorpropamide);
- diarrhea (such as loperamide);
- pain and inflammation (so-called NSAIDs).
The effect of Desmopressina Teva may be reduced if it is taken at the same time as some
medicines for:
- presence of gas in the stomach (such as dimethicone).
Desmopressina Teva with drinks
If you are taking this medicine for nocturnal enuresis or nocturia, you should limit
fluid intake starting 1 hour before taking the tablet and up to 8 hours after
taking it.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Experience with the use of desmopressin during pregnancy is limited.
Desmopressina Teva passes into breast milk, but it is unlikely to affect breastfed infants.
Driving and using machines
Desmopressina Teva does not alter or negligibly alters the ability to drive vehicles and operate
machinery.
Desmopressina Teva contains lactose(a type of sugar). If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking this medicine.
Desmopressina Teva contains sodium. This medicine contains less than 1 mmol of sodium (23 mg)
per sublingual tablet, i.e. essentially “sodium-free”.
For athletes.The use of the drug without therapeutic necessity constitutes doping and
may still result in positive anti-doping tests.
3. How to take Desmopressina Teva
Take this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.
The dose is established by the doctor, who will adapt it to your case.
Desmopressina Teva must be taken at the same time each day.
The sublingual tablet must be placed under the tongue, where it dissolves without water.
Diabetes insipidus
The usual dose for adults and children is 1-2 tablets (containing 60 micrograms) under the tongue
3 times a day.
Nocturnal enuresis
The usual dose is 1-2 tablets (containing 120 micrograms) under the tongue in the evening. This medicine
must be taken at bedtime. Fluid intake should be limited.
The doctor will check every three months whether to continue treatment. They may also set a
treatment-free period of at least one week.
Nocturia in adults
The usual dose is 1 tablet (containing 60 micrograms) under the tongue at bedtime.
Fluid intake should be limited.
Use in children
This medicine is used to treat diabetes insipidus and nocturnal enuresis (see above for
dosage for the different conditions of treatment). The dosage is the same for children and adults
only in the case of diabetes insipidus.
If you take more Desmopressina Teva than you should
If you take more medicine than you should, or if, for example, a child has accidentally ingested the
medicine, contact a doctor, hospital or pharmacist immediately for advice and a
risk assessment.
Taking an excessive amount of Desmopressina Teva may prolong the effect of this
medicine and increase the risk of fluid retention in the body and a low level of sodium in the
blood. Symptoms of severe fluid retention include seizures and loss of consciousness.
If you forget to take Desmopressina Teva
Do not take a double dose to make up for a missed tablet.
If you have any doubts about using this medicine, ask your doctor or pharmacist.
If you stop taking Desmopressina Teva
If you have any doubts about using 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.
If fluid intake is not limited as described above, abnormal amounts of fluid may accumulate in the
body, which may result in headache, stomach discomfort, nausea/vomiting, weight gain, dizziness,
confusion, malaise, a feeling of lightheadedness and, in severe cases, convulsions and coma.
These signs may reflect more or less significant fluid retention. They usually appear with high doses of
Desmopressina Teva and disappear when the dose is reduced.
Adults
Very common(may affect more than 1 in 10 people)
- Headache.
Common(may affect up to 1 in 10 people)
- Low levels of sodium in the blood
- Dizziness
- High blood pressure
- Stomach discomfort
- Nausea
- Diarrhoea
- Constipation
- Vomiting
- Discomfort of the bladder and urethra
- Swelling of hands, arms, feet or legs
- Fatigue. Not common(may affect up to 1 in 100 people)
- Difficulty sleeping
- Drowsiness
- Tingling
- Visual disturbances
- General feeling of spinning (vertigo)
- Feeling the heartbeat
- Low blood pressure when getting up
- Shortness of breath
- Stomach disorders (indigestion, flatulence, bloated stomach)
- Sweating
- Itching
- Skin rash
- Hives
- Muscle spasms
- Muscle pain
- Chest pain
- Flu-like symptoms
- Weight gain
- Increased levels of liver enzymes
- Low levels of potassium in the blood.
Rare(may affect up to 1 in 1,000)
- Confusion
- Allergic dermatitis.
Frequency not known(frequency cannot be estimated from the available data)
- Anaphylactic reaction (severe allergic reaction)
- Dehydration
- High levels of sodium in the blood
- Convulsions
- Weakness
- Coma.
Children
Common(may affect up to 1 in 10 people)
- Headache.
Not common(may affect up to 1 in 100 people)
- Rapid change of emotions
- Aggressiveness
- Nausea
- Stomach discomfort
- Vomiting
- Diarrhoea
- Discomfort of the bladder and urethra
- Hands and feet swelling
- Fatigue. Rare(may affect up to 1 in 1,000)
- Symptoms of anxiety
- Nightmares
- Mood swings
- Drowsiness
- High blood pressure
- Irritability. Frequency not known(frequency cannot be estimated from the available data)
- Anaphylactic reaction (severe allergic reaction)
- Low levels of sodium in the blood
- Abnormal behaviour
- Emotional disorders
- Depression
- Hallucinations
- Difficulty sleeping
- Attention deficit
- Increased muscle movements
- Cramps
- Nosebleeds
- Skin rash
- Allergic dermatitis
- Sweating
- Hives.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system reported 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 Desmopressina Teva
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 blister, the label, the
box or the bottle after “Exp.”. The expiry date refers to the last day of that month.
[For blisters]
Store in the original blister pack, protected from moisture. This medicine does not require any
special temperature conditions for storage.
[For HDPE containers]
Store in the original packaging. Keep the bottle tightly closed, protected from moisture. This
medicine does not require any special temperature conditions for storage.
Do not dispose of any medicine in 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 Desmopressina Teva contains
- The active ingredient is desmopressin. Desmopressina Teva 60 micrograms sublingual tabletsEach tablet contains 60 micrograms of desmopressin (as desmopressin acetate).
- Desmopressina Teva 120 micrograms sublingual tabletsEach tablet contains 120 micrograms of desmopressin (as desmopressin acetate).
- The other ingredients are: lactose monohydrate, corn starch, citric acid (E 330), sodium croscarmellose (E 468), magnesium stearate (E 470b)
Description of the appearance of Desmopressina Teva and package contents
Desmopressina Teva 60 micrograms sublingual tablets
White or almost white, round and biconvex tablets, with the inscription “I” imprinted on one
side and smooth on the other side, with a diameter of 6.5 mm and a thickness of 2 mm.
Desmopressina Teva 120 micrograms sublingual tablets
White or almost white, octagonal and biconvex tablets, with the inscription “II” imprinted on
one side and smooth on the other side, with a length/width of 6.5 mm and a thickness of 2 mm.
Desmopressina Teva is supplied in a cardboard box containing OPA/Al/PVC/PE-Al blisters
with an integrated desiccant in packs of 10, 20, 30, 50, 60, 90 or 100 sublingual tablets or
perforated blisters divisible for single doses of 10x1, 20x1, 30x1, 50x1, 60x1, 90x1 or 100x1 tablets
sublingually, or in HDPE bottles equipped with PP caps with an integrated desiccant containing 30 or
100 sublingual tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milano
and manufacturer
Haupt Pharma Mϋnster GmbH
Schleebrüggenkamp 15,
D-48159 Münster, Germany
Adalvo Ltd.
Malta Life Sciences Park,
Building 1, Level 4, Sir Temi Zammit Buildings,
San Gwann, SGN 3000, Malta
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- Kraj rejestracji
- Postać farmaceutycznaSublingual tablet, 60 MICROGRAMS
- Kod ATCH01BA02
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki DESMOPRESSINA TEVAPostać farmaceutyczna: Sublingual tablet, 60 MICROGRAMSSubstancja czynna: desmopressinProducent: ZENTIVA ITALIA S.R.L.Wymaga receptyPostać farmaceutyczna: Injectable solution, 4 MCG/0.5 MLSubstancja czynna: desmopressinProducent: KEDRION S.P.A.Wymaga receptyPostać farmaceutyczna: Injectable solution, 4 MCG/MLSubstancja czynna: desmopressinProducent: FERRING S.P.A.Bez recepty
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Często zadawane pytania
DESMOPRESSINA TEVA wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w DESMOPRESSINA TEVA jest desmopressin. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
DESMOPRESSINA TEVA jest produkowany przez TEVA ITALIA 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 DESMOPRESSINA TEVA 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 DESMOPRESSINA TEVA 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 (desmopressin) to m.in. DESMOPRESSINA TSENTIVA, EMOSINT, MINIRIN/DDAVP. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
