DESMOPRESSIN TEVA

Package leaflet: Information for the user

Desmopressin Teva 60 microgram sublingual tablets, 120 microgram sublingual tablets

Generic medicine
Please 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, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Desmopressina Teva is and what it is used for

Desmopressin, the active substance 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 disorder of the pituitary gland causing severe thirst and the production of large amounts of urine, usually pale and watery).
• Nocturnal enuresis in children from the age of 5 years with normal urine concentrating ability (a condition characterized by involuntary urination during sleep).
• Nocturia in adults under 65 years of age (a condition in which a person wakes up frequently during the night to urinate).

2. What you need to know before taking Desmopressin Teva

Do not take Desmopressin Teva:

• if you are allergic to desmopressin or to any of the other ingredients of this medicine (listed in section 6);
• if you have polydipsia (abnormal intake of large amounts of fluids), heart failure, or other conditions requiring treatment with diuretics;
• if you have moderate or severe impairment of 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 hormonal secretion disorder (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
modifications and the use of a bedwetting alarm (a device that emits a sound or vibration at the time of
urine loss) should be tried first. If these measures are ineffective or if pharmacological treatment is
required, desmopressin treatment may be initiated.
Talk to your doctor before using Desmopressin Teva:

• if you have coronary heart disease (affecting the blood vessels supplying the heart) or high blood pressure;
• if you have a thyroid gland (a gland located in the throat) or adrenal gland (a gland located above the kidney) disorder;
• if during treatment you develop an illness causing fever, vomiting, or diarrhoea;
• if during treatment you experience headache, loss of appetite, nausea, vomiting, weight gain, confusion (difficulty understanding words, attention problems), or seizures (violent, involuntary contractions of one or more limbs); these symptoms may be signs of a serious condition called hyponatraemia (low sodium levels in the blood);
  • for the treatment of central diabetes insipidus: it is necessary to reduce water intake and contact a doctor immediately. The doctor will reduce the dose or suspend treatment for a few hours;
  • for the treatment of nocturnal enuresis or nocturia: it is necessary to stop treatment, reduce water intake, and contact a doctor immediately;
• if you are at risk of increased intracranial pressure.

When treating nocturnal enuresis and nocturia, fluid intake must be reduced to the minimum necessary to
quench thirst during the period from 1 hour before up to 8 hours after taking this medicine.
Desmopressin Teva should be used with caution in patients with disturbances of water balance.
Contact your doctor if, in association with an acute illness, you develop disturbances in water and/or
electrolyte balance.
Children
This medicine should be used in children under the supervision of an adult.
Do not give this medicine to children under 5 years of age.
Other medicines and Desmopressin Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
The effect of Desmopressin Teva may be increased, with a higher risk of abnormal fluid accumulation in the body, if taken concomitantly with certain 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);
• diarrhoea (such as loperamide);
• pain and inflammation (so-called NSAIDs).

The effect of Desmopressin Teva may be reduced if taken concomitantly with certain medicines for:

• stomach gas (such as dimethicone).

Desmopressin Teva and drinks
If you are taking this medicine for nocturnal enuresis or nocturia, you must limit fluid intake from 1 hour before taking the tablet up to 8 hours after taking it.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Experience with the use of desmopressin during pregnancy is limited.
Desmopressin Teva passes into breast milk, but it is unlikely to affect breastfed infants.
Driving and using machines
Desmopressin Teva does not affect or has a negligible effect on the ability to drive vehicles and use machines.
Desmopressin Teva contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
Desmopressin Teva contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per sublingual tablet, i.e. essentially “sodium-free”.
For those engaged in sports. Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take Desmopressina Teva

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
The dose will be determined by your doctor, who will adjust it according to your individual needs.
Desmopressina Teva should always 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 (60 micrograms each) under the tongue, three times daily.

Nocturnal enuresis
The usual dose is 1–2 tablets (120 micrograms each) under the tongue in the evening. This medicine should be taken at bedtime. Fluid intake must be limited.
Your doctor will review every three months whether treatment should continue. Your doctor may also schedule a treatment-free period of at least one week.

Nocturia in adults
The usual dose is 1 tablet (60 micrograms) under the tongue at bedtime. Fluid intake must be limited.

Use in children
This medicine is used to treat diabetes insipidus and nocturnal enuresis (see dosage above for the different conditions). The dosage for children is the same as for adults only in the case of diabetes insipidus.

If you take more Desmopressina Teva than you should
If you take more than the prescribed amount, or if, for example, a child accidentally ingests the medicine, contact a doctor, hospital, or pharmacist immediately for advice and risk assessment.
Taking an excessive amount of Desmopressina Teva may prolong the medicine's effect and increase the risk of fluid retention in the body and low sodium levels in the blood. Symptoms of severe fluid retention include seizures and unconsciousness.

If you forget to take Desmopressina Teva
Do not take a double dose to make up for the forgotten tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

If you stop taking Desmopressina Teva
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 everyone gets them.
If fluid intake is not limited as indicated above, abnormal amounts of fluid may accumulate in the body, which can lead to headache, stomach pain, nausea/vomiting, weight gain, dizziness, confusion, malaise, vertigo, and, in severe cases, seizures and coma.
These signs may reflect mild to significant fluid retention. They usually occur with high doses of Desmopressin 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 sodium levels in the blood
• Dizziness
• High blood pressure
• Stomach pain
• Nausea
• Diarrhoea
• Constipation
• Vomiting
• Bladder and urethral discomfort
• Swelling of hands, arms, feet or legs
• Fatigue.

Uncommon (may affect up to 1 in 100 people)

• Difficulty sleeping
• Drowsiness
• Tingling sensation
• Visual disturbances
• General sensation of spinning (vertigo)
• Awareness of heartbeat
• Low blood pressure upon standing
• Shortness of breath
• Stomach disturbances (indigestion, flatulence, bloated stomach)
• Sweating
• Itching
• Rash
• Hives
• Muscle spasms
• Muscle pain
• Chest pain
• Influenza-like symptoms
• Weight gain
• Increased liver enzyme levels
• Low potassium levels in the blood.

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

• Confusion
• Allergic dermatitis.

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

• Anaphylactic reaction (severe allergic reaction)
• Dehydration
• High sodium levels in the blood
• Seizures
• Weakness
• Coma.

Children
Common (may affect up to 1 in 10 people)

• Headache.

Uncommon (may affect up to 1 in 100 people)

• Rapid mood changes
• Aggressiveness
• Nausea
• Stomach pain
• Vomiting
• Diarrhoea
• Bladder and urethral discomfort
• Swollen hands and feet
• Fatigue.

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

• Anxiety symptoms
• 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 sodium levels in the blood
• Abnormal behaviour
• Emotional disturbances
• Depression
• Hallucinations
• Difficulty sleeping
• Attention deficit
• Increased muscle movements
• Cramps
• Nosebleeds
• Rash
• Allergic dermatitis
• Sweating
• Hives.

Reporting of side effects
If you experience any side effects, 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: 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 Desmopressin Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, label, box, or 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 special storage temperature conditions.
[For HDPE containers]
Store in the original packaging. Keep the bottle tightly closed and protected from moisture. This medicine does not require special storage temperature conditions.
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 Desmopressina Teva contains

• The active substance is desmopressin. Desmopressina Teva 60 microgrammi compresse sublinguali: Each tablet contains 60 micrograms of desmopressin (as desmopressin acetate).
• Desmopressina Teva 120 microgrammi compresse sublinguali: Each tablet contains 120 micrograms of desmopressin (as desmopressin acetate).
• The other components are: monohydrate lactose, maize 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 microgrammi compresse sublinguali
White or almost white, round, biconvex tablets with the inscription “I” printed on one side and smooth on the other, 6.5 mm in diameter and 2 mm thick.
Desmopressina Teva 120 microgrammi compresse sublinguali
White or almost white, octagonal, biconvex tablets with the inscription “II” printed on one side and smooth on the other, 6.5 mm in length/width and 2 mm thick.
Desmopressina Teva is supplied in a cardboard box containing blisters made of OPA/Al/PVC/PE-Al with an integrated desiccant layer, in pack sizes of 10, 20, 30, 50, 60, 90 or 100 sublingual tablets, or perforated divisible blisters for single doses of 10x1, 20x1, 30x1, 50x1, 60x1, 90x1 or 100x1 sublingual tablets. Alternatively, it is supplied in HDPE bottles with PP caps and integrated desiccant containing 30 or 100 sublingual tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milano, Italy

Manufacturer
Haupt Pharma Münster 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