Pseurin

Package leaflet: Information for the patient

PSEURIN 0,1 mg tablets, 0,2 mg tablets

Desmopressin
Generic medicine
Read all of this leaflet carefully before you start 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 other people, 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 PSEURIN is and what it is 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

1. What PSEURIN is and what it is used for

DESMOPRESSIN contains the active substance desmopressin, which is very similar to the antidiuretic hormone (ADH) naturally produced by the body, regulating urine production.
This medicinal product is indicated for the treatment of:

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

2. What you should know before taking PSEURIN

Do not take PSEURIN

• if you are allergic to desmopressin or to any of the other ingredients of this medicine (listed in section 6);
• if you regularly drink large amounts of fluids (habitual polydipsia or psychogenic polydipsia);
• if you have severe heart problems (confirmed or suspected heart failure) or other disorders requiring treatment with medicines that increase urine production (diuretics);
• if you have kidney problems (moderate or severe renal impairment);
• if you have low levels of sodium in your blood (confirmed hyponatremia);
• if you suffer from a disorder affecting the production of antidiuretic hormone (syndrome of inappropriate antidiuretic hormone secretion, SIADH);
• if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking PSEURIN.

If you are taking PSEURIN for the treatment of primary nocturnal enuresis, limit fluid intake as much as possible, as this may lead to water accumulation in the body and/or reduced sodium levels in the blood, causing certain adverse effects (headache, nausea/vomiting, weight gain, and in severe cases, seizures) (see section “How to take PSEURIN”). It is also recommended to empty your 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 any of the following apply to you:

• you have bladder problems (severe bladder dysfunction or obstruction);
• you are elderly or have low sodium levels in your blood, as excessively low sodium levels (hyponatremia) may occur;
• you have an imbalance of fluids and electrolytes in your body, especially if caused by systemic infections, fever, or gastrointestinal infections (gastroenteritis). In such cases, your doctor will discontinue treatment with this medicine;
• you are at risk of increased intracranial pressure;
• you are taking medicines that may cause a disorder in antidiuretic hormone production (syndrome of inappropriate antidiuretic hormone secretion, SIADH), such as tricyclic antidepressants, selective serotonin reuptake inhibitors, chlorpromazine, carbamazepine, non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and PSEURIN”). In such cases, your doctor should periodically monitor your blood (serum) sodium levels to prevent them from becoming too low (hyponatremia);
• you have heart or circulatory problems (coronary insufficiency) or high blood pressure (arterial hypertension);
• you have asthma;
• you have epilepsy;
• you suffer from severe headaches (migraine);
• you have a serious disease affecting the bronchi and lungs (cystic fibrosis).

Attention for athletes: The product contains substances prohibited in doping. Any use differing from the prescribed dosage regimen or route of administration is forbidden.

Other medicines and PSEURIN
Inform 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, as they may increase the risk of certain adverse effects (fluid retention, hyponatremia):

• tricyclic antidepressants, selective serotonin reuptake inhibitors, used to treat depression;
• chlorpromazine, used to treat certain mental disorders;
• carbamazepine, used to treat epilepsy;
• sulfonylureas such as chlorpropamide, used to treat diabetes, as they may enhance the effect of PSEURIN;
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat inflammation;
• loperamide, used to treat diarrhea.

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

PSEURIN with food, drinks 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, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take PSEURIN if you are pregnant, except in cases of absolute necessity and under strict medical supervision.

Breastfeeding
Consult your doctor about the use of this medicine during breastfeeding.

Driving and using machines
This medicine does not alter or alters negligibly the ability to drive or use machinery.

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

3. How to take PSEURIN

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the most appropriate dose for you.

Treatment of pituitary, idiopathic or symptomatic diabetes insipidus
Adults and children
The recommended starting dose is 1 tablet (0.1 mg), 3 times daily. If necessary, your 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 daily.

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

If you take more PSEURIN than you should
Taking an excessive dose of this medicine may cause reduced urine output (fluid retention) and reduced sodium levels in the blood (hyponatremia).
Your doctor will decide the most appropriate treatment for you, depending on the severity of symptoms.
In case of accidental ingestion/overdose of PSEURIN, contact your doctor immediately 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 how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get 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 in blood sodium levels (hyponatremia)*;
• dizziness;
• increased blood pressure (hypertension);
• nausea, abdominal pain, diarrhoea, constipation, vomiting;
• urinary tract disorders (bladder and urethra);
• swelling due to fluid accumulation (oedema), fatigue.

Uncommon (may affect up to 1 in 100 people)

• insomnia;
• somnolence, tingling and numbness sensations in arms and legs (paraesthesia);
• visual disturbances;
• vertigo;
• increased awareness of heartbeat (palpitations);
• dizziness when standing up, due to a rapid drop in blood pressure (orthostatic hypotension);
• difficulty breathing (dyspnoea);
• digestive disorders (dyspepsia), flatulence, intestinal bloating and distension;
• sweating, itching, skin irritations (rash, urticaria);
• involuntary muscle contractions (muscle spasms), muscle pain (myalgia);
• malaise, chest pain, flu-like symptoms (influenza-like syndrome);
• weight gain, altered liver function (increased liver enzymes), reduced blood potassium levels (hypokalaemia).

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

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

Frequency not known (frequency cannot be estimated from the available data):

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

* observed 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)

• emotional instability (affective lability), aggression;
• abdominal pain, nausea, vomiting, diarrhoea;
• urinary tract disorders (bladder and urethra);
• swelling of feet and ankles due to fluid accumulation (peripheral oedema), fatigue.

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

• anxiety symptoms, nightmares, mood swings, mainly reported in children under 12 years of age;
• somnolence;
• increased blood pressure (hypertension);
• irritability.

Frequency not known (frequency cannot be estimated from the available data):

• severe allergic reactions (anaphylactic reactions);
• reduction in blood sodium levels (hyponatremia);
• abnormal behaviour, emotional disturbances (emotional disorders), depression, hallucinations, insomnia;
• attention disorders, excessive behavioural and motor activity (psychomotor hyperactivity), seizures;
• nosebleeds (epistaxis);
• skin irritations (allergic dermatitis, rash, urticaria), sweating.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can 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 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 above 25°C.
Keep 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 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 PSEURIN contains
PSEURIN 0.1 mg tablets

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

PSEURIN 0.2 mg tablets

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

Description of the appearance of PSEURIN and contents of the pack
PSEURIN 0.1 mg tablets
Box containing 30 tablets.
PSEURIN 0.2 mg tablets
Box containing 30 tablets.

Marketing Authorization Holder
Farto S.r.l., Via Dei Caboto 49, 50127 Florence, Italy
Manufacturer
LA.FA.RE. S.r.l. - Via Sacerdote Benedetto Cozzolino, 77 - 80056 Ercolano (NA), Italy