Desmopressin Teva 120 micrograms sublingual tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desmopresin Teva 120 micrograms sublingual tablets EFG

Desmopresin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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 the side effect is not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Desmopressin, the active ingredient in Desmopresin Teva, is an analogue of the natural hormone vasopressin, which regulates the kidneys' ability to concentrate urine.

Desmopresin Teva 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).
• Nocturnal enuresis in children aged 5 years and older with normal urine concentrating ability (involuntary urination during sleep at night).
• Nocturia (a condition in which a person wakes up frequently during the night to urinate) in adults under 65 years of age.

2. What you need to know before starting to take Desmopresina Teva

Do not take Desmopresina Teva:

• 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 are unable to comply with fluid restriction
• if you have an altered hormone secretion (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

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

Consult your doctor before starting to take 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 (glands above the kidneys)
• 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 consult 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 consult a doctor immediately.
• if you are at risk of increased intracranial pressure

When treating nocturnal enuresis or nocturia, fluid intake should be limited to the minimum necessary to manage 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 disturbances in fluid balance. Speak with your doctor if, due to an acute illness, you develop an imbalance in your water and electrolyte levels.

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.

Use of other medicines with Desmopresina Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines obtained 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 (so-called sulfonylureas, e.g., chlorpropamide)
• diarrhea (such as loperamide)
• pain and inflammation (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)

Taking Desmopresina Teva with food and drink

The effect of this medicine may be reduced if taken with food.

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 or breastfeeding, think you may be pregnant, or plan 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 is unlikely to affect breastfed infants.

Driving and use of machines

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

Desmopresina Teva contains lactose and sodium

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; this is essentially “sodium-free”.

3. How to take Desmopresin Teva

Follow exactly the instructions for use of this medicine as given by your doctor. 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 in relation to meals.

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

Diabetes insipidus in adults and children:

The usual dose is 1 to 2 tablets under the tongue (60 microgram tablet) 3 times daily.

Enuresis in adults and children aged 5 years and older:

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 bedtime.

Fluid intake should be restricted.

Use in children

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

If you take more Desmopresin Teva than you should

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

If you take more of this 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 Desmopresin Teva may prolong the effect of the 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 Desmopresin Teva

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 Desmopresin Teva

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 may 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 resolve 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 effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 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, carton or bottle after EXP. The expiry date refers to the last day of the month indicated.

Blister packs

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

HDPE bottles

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desmopresin Teva

• The active substance is desmopressin.

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

• The other components are: lactose monohydrate, maize starch, citric acid (E330), sodium croscarmellose (E468), magnesium stearate (E470b).

Appearance of the medicine and contents of the pack

White or almost white, octagonal, biconvex tablet, engraved with "II" on one side and smooth on the other, 6.5 mm in length/width and 2 mm thick.

Desmopresin Teva is supplied in a cardboard box containing OPA/Al/PVC/PE-Al blisters with an integrated desiccant layer, in pack sizes of 10, 20, 30, 50, 60, 90, or 100 sublingual tablets; or unit-dose perforated blisters of 10, 20, 30, 50, 60, 90, and 100 sublingual tablets; or in HDPE bottles with PP cap and integrated desiccant containing 30 or 100 sublingual tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

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

For further information about this medicine, contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid (Spain)

Date of the most recent revision of this leaflet: June 2023

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