PSEURIN 0.1 MG Таблетки

Содержание инструкции

1. PSEURIN 0.1 mg tablets, 0.2 mg tablets
   1. What is PSEURIN and what is it used for
   2. What you need to know before taking PSEURIN
   3. How to take PSEURIN
   4. Possible side effects
   5. How to store PSEURIN
   6. Contents of the pack and other information

PSEURIN 0.1 mg tablets, 0.2 mg tablets

Desmopressin

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

1. What is PSEURIN and what is it used for

DESMOPRESSINA contains the active ingredient desmopressin, very similar to the antidiuretic hormone
(ADH) naturally produced by the body, which acts by regulating urine production.
This medicine is indicated for the treatment of:

• Diabetes insipidus, characterized by extreme thirst and production of large amounts of urine, which can be caused by problems with the pituitary gland (hypophyseal), by other diseases (symptomatic) or without evident causes (idiopathic);
• Nocturnal enuresis (primary nocturnal enuresis), in children over 5 years of age.

2. What you need to know before taking PSEURIN

Do not take PSEURIN

• if you are allergic to desmopressin or any of the other ingredients of this medicine (listed in section 6);
• if you drink large amounts of liquids habitually (habitual or psychogenic polydipsia)
• if you suffer from severe heart problems (established or suspected heart failure) or other disorders that require treatment with medicines that facilitate urine production (diuretics);
• if you suffer from kidney problems (moderate or severe renal insufficiency)
• if you have low levels of sodium in the blood (established hyponatremia);
• if you suffer from a disorder of the production of the antidiuretic hormone (syndrome of inappropriate ADH secretion, SIADH);
• if you are pregnant (see section “Pregnancy and breastfeeding”). Warnings and precautionsTalk to your doctor or pharmacist before taking PSEURIN.

If you take PSEURIN for the treatment of primary nocturnal enuresis, limit fluid intake as much as possible
as this may lead to an accumulation of water in the body and/or a
reduction in blood sodium levels with the appearance of some undesirable effects (headache,
nausea/vomiting, weight gain, and in severe cases, convulsions) (see section “How to take
PSEURIN”). It is also recommended to empty the bladder before taking the medicine.
During treatment with PSEURIN, you must carefully reduce fluid intake, including
alcohol.
Take this medicine with caution and inform your doctor if:

• you suffer from bladder problems (severe bladder dysfunctions or obstructions);
• you are elderly or have low levels of sodium in the blood, because a excessive reduction in blood sodium levels (hyponatremia) may occur;
• you have an imbalance of fluids and salts in the body (fluid and electrolyte imbalance), especially if caused by infections affecting the whole body (systemic), fever or infections of the stomach and intestines (gastroenteritis). In this case, your doctor will stop treatment with this medicine;
• you are at risk of increased pressure in the brain (intracranial);
• you are taking medicines that can cause a disorder of the production of the antidiuretic hormone (syndrome of inappropriate ADH secretion, SIADH) such as tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, carbamazepine, non-steroidal anti-inflammatory drugs (NSAIDs), (see section “Other medicines and PSEURIN”). In this case, your doctor should periodically check blood sodium levels (serum) to prevent them from being too low (hyponatremia).
• you suffer from heart and circulation problems (coronary insufficiency) or if you suffer from high blood pressure (arterial hypertension);
• you suffer from asthma;
• you suffer from epilepsy;
• you have severe headaches (migraine);
• you suffer from a severe disease affecting the bronchi and lungs (cystic fibrosis).

Attention for those who engage in sports: the product contains substances prohibited for doping. Taking it in a manner different from the prescribed dosage regimen and route of administration is prohibited.

Other medicines and PSEURIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Take PSEURIN with caution and inform your doctor if you are taking the following medicines because
they may increase the risk of certain side effects (fluid retention, hyponatremia):

• tricyclic antidepressants, selective serotonin re-uptake inhibitors, used for the treatment of depression;
• chlorpromazine, used for the treatment of some mental disorders;
• carbamazepine, used for the treatment of epilepsy;
• sulfonylureas such as chlorpropamide, used for the treatment of diabetes, as they may increase the effect of PSEURIN;
• non-steroidal anti-inflammatory drugs (NSAIDs) used for the treatment of inflammation;
• loperamide, used for the treatment of diarrhea.

Take PSEURIN with caution and inform your doctor if you are taking glibenclamide, used for the
treatment of diabetes, because it may reduce the effect of desmopressin.

PSEURIN with food, beverages and alcohol
At low doses, this medicine may be affected by food intake.
Avoid drinking alcoholic beverages during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take PSEURIN if you are pregnant, unless absolutely necessary and under strict
medical supervision.

Breastfeeding
Ask your doctor for advice on the use of this medicine while breastfeeding.

Driving and operating machinery
This medicine does not or negligibly alters the ability to drive vehicles or
operate machinery.

PSEURIN contains lactose
This medicine contains lactose, a type of sugar. If you have been diagnosed by your
doctor with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take PSEURIN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The doctor will establish the dose to be taken that is most suitable for you.

Treatment of pituitary, idiopathic or symptomatic diabetes insipidus
Adults and children
The recommended initial dose is 1 tablet (0.1 mg), 3 times a day. If necessary, the doctor
may decide to increase the dose up to 1.2 mg per day.
Generally, the recommended optimal dose is 1 tablet (0.1 – 0.2 mg), 3 times a day.

Treatment of primary nocturnal enuresis
Adults and children over 5 years of age
The recommended initial dose is 1 tablet (0.2 mg) to be taken in the evening, before bedtime, after
emptying the bladder (See paragraph “Warnings and precautions”).
If necessary, the doctor may increase the dose (up to 0.4 mg).
Limit the intake of fluids from 1 hour before taking the tablet to at least 8 hours after
taking it (see paragraph “Warnings and precautions”).
If you take this medicine for a long time, after 3 months of treatment, the doctor will
ask you to stop taking PSEURIN for at least 1 week and will subject you to careful monitoring.
Stop treatment and inform your doctor if you experience headache, nausea, vomiting, weight gain and, in more severe cases, convulsions, which are symptoms of poor fluid elimination
(fluid retention) or reduced sodium levels in the blood (hyponatremia). When the
treatment is resumed, fluid intake must be strictly controlled.

If you take more PSEURIN than you should
In case of taking an excessive dose of this medicine, reduced
urine elimination (fluid retention) and a reduction in blood sodium levels (hyponatremia) may occur.
The doctor will establish the most appropriate therapy for you, based on the severity of the symptoms.
In case of accidental ingestion/intake of an excessive dose of PSEURIN, immediately notify
your doctor or go to the nearest hospital.

If you forget to take PSEURIN
Do not take a double dose to make up for the missed tablet.
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 gets them.
The following side effects may occur:

Very common(may affect more than 1 in 10 people)

• headache.

Common(may affect up to 1 in 10 people)

• reduction of sodium levels in the blood (hyponatremia)*;
• dizziness;
• increased blood pressure (hypertension);
• nausea, abdominal pain, diarrhea, constipation, vomiting;
• urinary tract disorders (of the bladder and urethra);
• swelling due to fluid retention (edema), fatigue. Uncommon(may affect up to 1 in 100 people)
• insomnia;
• sleepiness, tingling and numbness in the arms and legs (paresthesia);
• vision disorders;
• vertigo;
• increased awareness of heartbeats (palpitations);
• feeling dizzy when standing up, due to a rapid drop in blood pressure (orthostatic hypotension);
• difficulty breathing (dyspnea);
• digestive disorders (dyspepsia), flatulence, bloating and dilation of the intestine;
• sweating, itching, skin irritation (rash, urticaria);
• involuntary muscle contractions (muscle spasms), muscle pain (myalgia);
• malaise, chest pain, flu-like symptoms (flu-like syndrome);
• weight gain, altered liver function (increased liver enzymes), reduced potassium levels in the blood (hypokalemia).

Rare(may affect up to 1 in 1,000 people)

• confusion (confusional state);
• skin irritation (allergic dermatitis).

Frequency not known(the frequency of which cannot be estimated on the basis of available data):

• serious allergic reactions (anaphylactic reactions);
• fluid loss (dehydration)*, increased sodium levels in the blood (hypernatremia)*;
• convulsions, feeling of weakness (asthenia)* loss of consciousness (coma).

* noted only in the indication of diabetes insipidus.

Additional side effects in children and adolescents
Common(may affect up to 1 in 10 people)

• headache.

Uncommon(may affect up to 1 in 100 people)

• mood instability (emotional lability), aggressiveness;
• abdominal pain, nausea, vomiting, diarrhea;
• urinary tract disorders (of the bladder and urethra);
• swelling of the feet and ankles due to fluid retention (peripheral edema), fatigue.

Rare(may affect up to 1 in 1,000 people)

• anxious symptoms, nightmares, fluctuating mood, reported mainly in children under 12 years of age;
• sleepiness;
• increased blood pressure (hypertension);
• irritability.

Frequency not known(the frequency of which cannot be estimated on the basis of available data):

• serious allergic reactions (anaphylactic reactions);
• reduction of sodium levels in the blood (hyponatremia);
• abnormal behavior, emotional disturbances (emotional disorders), depression, hallucinations, insomnia;
• attention disorders, excessive activity of behavior and movements (psychomotor hyperactivity), convulsions;
• nosebleeds (epistaxis);
• skin irritation (allergic dermatitis, rash, urticaria), sweating.

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 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 PSEURIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Store in the original packaging to protect the medicine from light and moisture.
Do not discard the capsule containing the desiccant.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What PSEURIN contains
PSEURIN 0.1 mg tablets

• The active ingredient is desmopressin. Each tablet contains 0.1 mg of desmopressin acetate (equivalent to 0.089 mg of desmopressin).
• The other ingredients are: lactose monohydrate, corn starch, povidone and magnesium stearate.

PSEURIN 0.2 mg tablets

• The active ingredient is desmopressin. Each tablet contains 0.2 mg of desmopressin acetate (equivalent to 0.178 mg of desmopressin).
• The other ingredients are: lactose monohydrate, corn starch, povidone and magnesium stearate.

Description of the appearance of PSEURIN and contents of the pack
PSEURIN 0.1 mg tablets
Bottle of 30 divisible tablets.

PSEURIN 0.2 mg tablets
Bottle of 30 divisible tablets.

Marketing Authorisation Holder
Farto S.r.l., Via Dei Caboto 49, 50127 Florence, Italy

Manufacturer
DOPPEL FARMACEUTICI S.r.l. – Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC) – Italy