Prospecto: information for the patient

Desmopresina Teva 120 micrograms sublingual tablets EFG

Desmopresina

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4

1. What isDesmopresina Tevaand for what it is used

2. What you need to know before starting to takeDesmopresina Teva

3. How to takeDesmopresina Teva

4. Possible adverse effects

5. Storage ofDesmopresina Teva

6. Contents of the package and additional informationl

Desmopresina, the active ingredient of Desmopresina Teva, is a natural vasopressin hormone analog that regulates the kidneys' ability to concentrate urine.

Desmopresina Teva is used for the treatment of:

• Central diabetes insipidus (a pituitary disorder that leads to intense thirst and the production of a large amount of pale, watery urine).
• Nocturnal enuresis in children aged 5 years and above with normal ability to concentrate urine (involuntary nighttime urination during sleep).
• Nocturia in adults under 65 years (a condition in which a person frequently wakes up at night to urinate).

Do not take Desmopresina Teva:

• if you are allergic to desmopresin or any of the other ingredients of this medicine (listed in section 6)
• if you have polydipsia (abnormally high intake of liquids), heart failure, and other conditions that require treatment with diuretics
• if you have a moderately or severely reduced renal function
• if you have low sodium levels in your blood
• if you cannot adhere to fluid restriction
• if you have altered hormone secretion (SIADH)
• if you are over 65 years old and have nocturia (see section 1)
• if your child is under 5 years old and has nocturnal enuresis (see section 1)

Warnings and precautions

The control of nocturnal enuresis (involuntary nocturnal urination) in children begins with lifestyle measures and an alarm for nocturnal enuresis (a device that produces a sound or vibrates when wet). If these measures fail or pharmacological therapy is needed, treatment with desmopresin can be initiated.

Consult your doctor before starting to take this medicine.

• if you have coronary artery disease (blood vessels that irrigate the heart) or high blood pressure
• if you have a thyroid disease (gland in the throat) or adrenal gland disease (gland above the kidney)
• if during treatment you have an illness that causes fever, vomiting, diarrhea.
• if during your treatment you feel headache, loss of appetite, nausea, vomiting, weight gain, confusion (difficulty understanding words, attention difficulties) or convulsions (violent and involuntary contractions of one or more limbs); these symptoms may be signs of a dangerous condition known as hyponatremia (low sodium levels in the blood)
• • for the treatment of central diabetes insipidus: you must reduce your water intake and consult a doctor immediately. Your doctor will reduce the doses or interrupt the treatment for some hours.
  • for the treatment of nocturnal enuresis or nocturia: you must suspend the treatment, reduce your water intake and consult a doctor immediately.
• if you have a risk of increased intracranial pressure

When treating nocturnal enuresis and nocturia, fluid intake should be limited to the minimum possible to control thirst during the period from 1 hour before to 8 hours after taking this medicine.

Desmopresina Teva should be used with caution in patients with fluid balance disorders. Talk to your doctor if, in relation to an acute illness, you have a hydroelectrolyte balance disorder.

Children

In children, the use of this medicine should be carried out under the supervision of an adult.

Do not administer this medicine to children under 5 years old.

Use of other medicines with Desmopresina Teva

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine, including over-the-counter medicines.

The effect of this medicine may increase, with a greater risk of abnormal fluid retention, if taken at the same time as 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, for example, chlorpropamide)
• diarrhea (such as loperamide)
• pain and inflammation (so-called NSAIDs)

The effect of this medicine may decrease if taken at the same time as certain medicines for:

• gas in the stomach (such as dimethicone)

Use of Desmopresina Teva with beverages

If you are taking this medicine for nocturnal enuresis or nocturia, you should limit your fluid intake from 1 hour before taking the tablet to 8 hours after taking it.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

The experience of use during pregnancy is limited.

Desmopresin passes into breast milk, but it is unlikely to affect infants.

Driving and operating machinery

Desmopresina Teva has a negligible or no effect on the ability to drive and operate machinery.

Desmopresina Teva contains lactose(a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Desmopresina Teva contains sodium.This medicine contains less than 1 mmol of sodium (23 mg) per sublingual tablet; this is, essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dosage is established by your doctor, who will adjust it individually for you.

This medication should be taken always at the same hour.

The sublingual tablet should be placed under the tongue where it dissolves without water.

Diabetes Insipidus:

The usual dose for adults and children is 1 to 2 sublingual tablets (60 microgram tablet) 3 times a day.

Enuresis:

The usual dose is 1-2 sublingual tablets (120 microgram tablet) under the tongue at night. Take this medication at bedtime. Fluid intake should be limited.

Your doctor will monitor you every three months to see if treatment should be continued. Your doctor may establish a period without treatment of at least one week.

Nocturia in Adults

The usual dose is 1 sublingual tablet (60 microgram tablet) under the tongue before bedtime.

Fluid intake should be limited.

Use in Children

This medication is used to treat diabetes insipidus and nocturnal enuresis (see above for dosage for different treatment conditions). The dose is the same for children and adults only for diabetes insipidus.

If you take more Desmopressin Teva than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone (91) 562 04 20 indicating the medication and the amount ingested. It is recommended to bring the packaging and the leaflet to the healthcare professional.

If you take more medication than you should or if, for example, a child has accidentally ingested the medication, contact a doctor, hospital, or pharmacist immediately for risk assessment and advice.

Taking too much Desmopressin Teva can prolong the effect of this medication and increase the risk of fluid retention in the body and low sodium levels in the blood. Severe fluid retention symptoms include seizures and loss of consciousness.

If you forgot to take Desmopressin Teva

Do not take double doses to compensate for the missed tablets.

If you have any other doubts about the use of this product, consult your doctor or pharmacist.

If you stop taking Desmopressin Teva

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If liquid intake is not limited according to the previous instructions, abnormal amounts of fluid may accumulate in your body, which can cause headaches, stomach pain, nausea/vomiting, weight gain, dizziness, confusion, general discomfort, feeling of spinning, and in severe cases, seizures and coma.

These signs may reflect a water retention that is more or less important. They usually appear with high doses of this medicine 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
• Hypertension
• Stomach pain
• Nausea
• Diarrhea
• Constipation
• Vomiting
• Urinary and urethral discomfort
• Swelling of hands, arms, feet, or legs
• Fatigue

Uncommon(may affect up to 1 in 100 people)

• Difficulty sleeping
• Somnolence
• Tickling
• Visual disturbances
• General feeling of spinning (dizziness)
• Feeling of heartbeats
• Low blood pressure upon standing
• Difficulty breathing
• Indigestion, flatulence, bloating
• Sweating
• Itching
• Rash
• Urticaria
• Muscle spasms
• Muscle pain
• Chest pain
• Symptoms similar to the flu
• Weight gain
• Increased liver enzymes
• Low potassium levels in the blood.

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

• Confusion
• Allergic skin inflammation.

Frequency not known(the 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)

• Emotional changes.
• Aggression
• Nausea
• Stomach pain
• Vomiting
• Diarrhea
• Urinary and urethral discomfort
• Swollen hands and feet
• Fatigue.

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

• Anxiety
• Nightmares
• Mood changes
• Somnolence
• Hypertension
• Irritability.

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

• Anaphylactic reaction (severe allergic reaction)
• Low sodium levels in the blood
• Abnormal behavior
• Emotional disturbances
• Depression
• Hallucinations
• Difficulty sleeping
• Reduced attention
• Increased muscle movements.
• Cramp
• Nasal bleeding
• Rash
• Allergic skin inflammation.
• Sweating
• Urticaria.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack, label, box, or bottle after CAD. The expiration date is the last day of the month indicated.

Blister Packs

Store in the original blister pack to protect it from moisture. This medication does not require any special storage temperature.

HDPE Bottles

Do not store at a temperature above 30°C. Store in the original packaging. Keep the bottle tightly closed to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit empty containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition ofDesmopressin Teva

- The active ingredient is desmopressin

Cada comprimido sublingual contiene 120 microgramos de desmopressina (como desmopresina acetato)

- The other components are: lactose monohydrate, cornstarch, citric acid (E330), sodium croscarmellose (E468), magnesium stearate (E470b)

Appearance of the product and contents of the packaging

Comprimido blanco o casi blanco, octogonal, biconvexo grabado con "II" en un lado y liso en el otro lado, con 6,5 mm de largo/ancho y 2 mm de espesor.

Desmopressin Tevase suministra en una caja de cartón que contiene blísteres de OPA/Al/PVC/PE-Al con una capa desecante integrada en tamaños de envase de 10, 20, 30, 50, 60, 90, 100 comprimidos sublinguales o blísteres perforados unidosis de 10, 20, 30, 50, 60, 90 y 100 comprimidos sublinguales, o en frascos de HDPE con tapón de PP con desecante integrado que contienen 30 o 100 comprimidos sublinguales.

Puede que solamente estén comercializados algunos tamaños de envases.

Holder of the Marketing Authorization and Responsible for manufacturing

Holder of the Marketing Authorization

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Responsible for Manufacturing

Haupt Pharma M?nster 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108, Madrid (Spain)

Date of the last review of this leaflet:June 2023

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/