Desmopressin Stada 120 micrograms sublingual tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desmopresina Stada 120 micrograms sublingual tablets EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Desmopresina Stada is and what it is used for

Desmopressin, the active substance in Desmopresina Stada, is an analogue of the natural hormone vasopressin, which regulates the kidneys' ability to concentrate urine.

Desmopressin is used to treat:

• Central diabetes insipidus (a pituitary disorder leading to intense thirst and the production of large amounts of urine, usually pale and watery).
• Enuresis in children aged 5 years and older who have a normal ability to concentrate urine (involuntary nighttime urination during sleep).
• Nocturia (a condition in which a person wakes frequently during the night to urinate) in adults under 65 years of age.

2. What you need to know before taking Desmopresin Stada

Do not take Desmopresin Stada:

• if you are allergic to desmopressin or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from polydipsia (abnormally high fluid intake), heart failure, or other conditions requiring treatment with diuretics
• if you have moderately or severely reduced kidney function
• if you have low levels of sodium in the blood
• if you cannot comply with fluid restriction
• if you have an altered hormone secretion (so-called SIADH)
• if you are over 65 years old and suffer from nocturia (see section 1)
• if your child is under 5 years old and suffers from nocturnal enuresis (see section 1)

Warnings and precautions

The management of nocturnal enuresis (involuntary nighttime urination) in children begins with lifestyle measures and a bedwetting alarm (a device that sounds or vibrates when wetting occurs). If these measures fail or pharmacological treatment is needed, treatment with desmopressin may be initiated.

Consult your doctor before starting this medicine

• if you have coronary artery disease (blood vessels supplying the heart) or high blood pressure
• if you have a thyroid gland disorder (a gland in the throat) or adrenal gland disorder (a gland above the kidney)
• if during treatment you develop an illness causing fever, vomiting, or diarrhea
• 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 known as hyponatremia (low sodium levels in the blood)
  • for the treatment of central diabetes insipidus: you must reduce water intake and contact a doctor immediately. Your doctor will reduce the dose or interrupt treatment for several hours.
  • for the treatment of nocturnal enuresis or nocturia: you must stop treatment, reduce water intake, and contact a doctor immediately.
• if you are at risk of increased intracranial pressure

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

Desmopressin should be used with caution in patients with disturbances in fluid balance. Speak with your doctor if, due to an acute illness, you have an electrolyte and fluid imbalance.

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 Desmopresin Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines without a prescription.

The effect of this medicine may be increased, with a higher risk of abnormal fluid retention in the body, 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 (the so-called sulfonylureas, e.g., chlorpropamide)
• diarrhea (such as loperamide)
• pain and inflammation (the so-called NSAIDs)

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

• stomach gas (such as simethicone)

Use of Desmopresin Stada with drinks

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

Pregnancy, breastfeeding, and fertility

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

Experience with use during pregnancy is limited.

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

Driving and using machines

Desmopressin has no or negligible effect on the ability to drive and use machines.

Desmopresin Stada contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per sublingual tablet; thus, it is essentially “sodium-free”.

3. How to take Desmopresina Stada

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The dose will be determined by your doctor, who will adjust it individually for you.

This medicine should always be taken at the same time.

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 to 2 tablets under the tongue (60 microgram tablet) 3 times daily.

Enuresis:

The usual dose is 1–2 tablets (120 microgram tablet) under the tongue at night. This medicine should be taken at bedtime. Fluid intake should be restricted.

Your doctor will monitor you every three months to assess whether treatment should continue. Your doctor may establish a treatment-free period of at least one week.

Nocturia in adults

The usual dose is 1 tablet (60 microgram tablet) under the tongue before going to bed.

Fluid intake should be restricted.

Use in children

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

If you take more Desmopresina Stada than you should

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

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

Taking too much desmopressin may prolong the effect of this medicine 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 loss of consciousness.

If you forget to take Desmopresina Stada

Do not take a double dose to make up for forgotten tablets.

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

If you stop taking Desmopresina Stada

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

These signs may reflect mild to significant water retention. They usually occur 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
• 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
• Visual disturbances
• General sensation of spinning (vertigo)
• Awareness of your heartbeat
• Low blood pressure upon standing from a lying position
• Difficulty breathing
• Stomach discomfort (indigestion, flatulence, bloating)
• Sweating
• Itching
• Rash
• Urticaria
• Muscle spasms
• Muscle pain
• Chest pain
• Flu-like symptoms
• 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 (frequency cannot be estimated from 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):

• Rapidly changing emotions
• Aggression
• Nausea
• Stomach pain
• Vomiting
• Diarrhea
• Bladder and urethral discomfort
• Swollen hands and feet
• Fatigue

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

• Anxiety
• Nightmares
• Mood changes
• Drowsiness
• Hypertension
• Irritability

Frequency not known (frequency cannot be estimated from 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
• Cramps
• Nosebleeds
• Rash
• Allergic skin inflammation
• Sweating
• Urticaria

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Desmopressin Stada

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

Store in the original packaging to protect it from moisture.

No special storage temperature is required for this medicine.

Do not use this medicine after the expiry date stated on the packaging, following CAD. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desmopressin Stada

• The active substance is desmopressin.

Each sublingual tablet contains 120 micrograms of desmopressin (as acetate).

• The other components are: lactose monohydrate, corn starch, citric acid, sodium croscarmellose, and magnesium stearate.

Appearance of the product and contents of the pack

Desmopressin Stada are white or almost white, octagonal, biconvex tablets engraved with 'II' on one side and smooth on the other, approximately 6.5 mm in length/width.

Desmopressin Stada is supplied in a cardboard box containing standard blisters or single-dose pre-cut blisters with an integrated aluminum/aluminum desiccant layer, each containing 10 sublingual tablets, in pack sizes of 10, 30, and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15,

D-48159 Münster,

Germany

or

Adalvo Ltd.

Malta Life Sciences Park,

Building 1, Level 4, Sir Temi Zammit Buildings,

San Gwann, SGN 3000

Malta

or

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel

Germany

Date of the most recent revision of this leaflet: June 2024

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/