Prospect: Information for the Patient

Desmopressin Teva 0.2 mg Tablets EFG

Read this prospect carefully before starting to take the 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 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.

The active ingredient that makes the tablet work (the active substance) is desmopresin. Desmopresin is a diuretic antagonist, which reduces the amount of urine produced by the kidneys

Desmopresina Teva is used to treat:

• Chronic disease calledcentral diabetes insipidus, which causes excessive thirst and the continuous formation of large amounts of urine.Important: Do not confuse with Diabetes mellitus (sugar diabetes)
• Enuresisin children (involuntary nocturnal urination) over 5 years old.

- Frequent need to urinate at nightin adults (nocturia).

Do not take Desmopresina Teva

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desmopresina Teva

Desmopresina Teva with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medication.

• Medications that increase the risk of fluid accumulation, which dilutes salt in the body
• • tricyclic antidepressants or SSRIs (used to treat depression)
  • carbamazepine(used to treat epilepsy)
  • chlorpromazine(used to treat psychosis or schizophrenia)
  • sulfonylureas(used to treat high blood sugar levels)
  • loperamide(used to treat diarrhea)
  • medications for pain and/or inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), for example indomethacin, ibuprofen.

• Medications that decrease the absorption of desmopresina
• • dimethicone(used in the treatment of symptoms due to gas accumulation in the intestines)

Desmopresina Teva with food and drinks

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 medication.

Desmopresina can be used during breastfeeding, but it should only be used during pregnancy if prescribed by a doctor. There is only limited experience with the use of Desmopresina in pregnant women with diabetes insipidus.

Driving and operating machinery

There is no evidence to suggest that Desmopresina Teva affects the ability to drive or operate machinery.

Desmopresina Teva contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

• During treatment with desmopressin, your body weight, blood sodium level, and/or blood pressure should be regularly monitored.

The recommended dose is:

• Central diabetes insipidus

Adults and children: 100 micrograms (0.1 mg) three times a day. Your doctor may increase the dose based on your response to symptoms.

• Nocturnal enuresis(involuntary nocturnal urination)

Children over 5 years old: 200 micrograms (0.2 mg) before bedtime. Your doctor may increase the dose up to 400 micrograms (0.4 mg) before bedtime based on your response to enuresis. The need to continue treatment is usually checked every three months by intercalating a period without treatment for at least one week.

• Frequent urination at night (nocturia)

Treatment of increased urination at night with desmopressin in adults (nocturia) should be initiated and controlled by specialists with experience in this treatment.

Adults: 100 micrograms (0.1 mg) before bedtime. The dose may be increased to 200 micrograms (0.2 mg) and, subsequently, up to a maximum of 400 micrograms (0.4 mg) with one-week intervals. Before starting treatment, urine production should be measured. If nocturia does not improve after four weeks, consult your doctor as treatment should be discontinued.

Older adults (over 65 years old): treatment of nocturia in the elderly is not recommended. If your doctor decides to treat you, blood sodium levels should be measured before and three days after starting treatment, and if the dose is increased or at any time your doctor considers necessary.

When using this medication for enuresis or nocturia, fluid intake should be reduced to a minimum 1 hour before taking a tablet until 8 hours after a dose.

Divide the tablets in half or take them whole. The groove is only to facilitate administration if you have difficulty swallowing the whole tablet.

Do not take this medication with food,as it may reduce the effectiveness of treatment. To ensure correct dosing, it is very important that you always pass the same time from taking the tablets and the next meal.

If you take more Desmopressin Teva than you should

A overdose may prolong the effect of desmopressin and increase the risk of fluid retention in the body and low blood sodium levels. Symptoms of fluid retention include seizures and loss of consciousness. If you take more Desmopressin Teva than prescribed, contact your doctor, pharmacist, or go to the nearest hospital.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91-562 04 20 indicating the medication and the amount ingested.

If you forgot to take Desmopressin Teva

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Desmopressin Teva

You should only change or discontinue treatment if your doctor indicates so.

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.

Stop treatment and consult your doctor immediately if the following occurs:

• Multiple or severe allergic symptoms and fluid retention. These include the following side effects listed with an asterisk (*).
• Hypersensitivity reactions such as skin rash, itching, fever, swelling of the mouth, tongue, or respiratory tract causing difficulty swallowing or respiratory problems.

Side effects observed in 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*
• Increased blood pressure
• Nausea*, abdominal pain*, diarrhea, constipation, vomiting*
• Urination problems (such as passing small amounts of water frequently, having a strong need to urinate)
• Fluid retention
• Fatigue

Uncommon(may affect up to 1 in 100 people)

• Insomnia
• Drowsiness, abnormal skin sensations
• Visual disturbances
• Dizziness*
• Palpitations
• Decreased blood pressure upon standing
• Difficulty breathing
• Gastrointestinal discomfort, e.g. stomach acid, flatulence, swelling
• Sweating, itching, skin rash, urticaria
• Muscle spasms, muscle pain
• Urinary symptoms
• Feeling unwell*
• Chest pain
• Symptoms similar to the flu
• Weight gain*
• Changes in liver function
• Low potassium levels in the blood

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

• Confusion*
• Skin allergy reaction

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

• Seizures*
• Loss of consciousness*
• In the treatment of central diabetes insipidus, dehydration, high sodium levels in the blood, and muscle weakness may occur.

Side effects observed in children up to 18 years of age

Common(may affect up to 1 in 10 people)

• Headache*

Uncommon(may affect up to 1 in 100 people)

• Emotional problems, aggression
• Abdominal pain*, nausea*, vomiting*, diarrhea
• Fluid retention in arms and legs
• Fatigue

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

• Anxiety, in children under 12 years old, nightmares and mood changes may also occur
• Drowsiness
• Increased blood pressure
• Irritability

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

• Low sodium levels in the blood*
• Abnormal behavior, emotional disorder, depression, hallucinations, insomnia
• Attention disorders, hyperactivity, seizures*
• Nasal bleeding
• Skin allergy reaction, skin rash, sweating, urticaria.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them through the Spanish System for the Pharmacovigilance of Medicines for Human Use website: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 packaging, blister, or bottle after “CAD”. The expiration date is the last day of the month indicated.

Blister: Do not store at a temperature above30°C

Bottle: Do not store at a temperature above30°C, keep the bottle perfectly closed to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment..

Composition of Desmopresina Teva

• The active ingredient is desmopressin acetate. Each 0.2 mg tablet contains 0.2 mg, equivalent to 0.178 mg of desmopressin.

• The other components are lactose monohydrate, cornstarch, povidone, pregelatinized starch, anhydrous colloidal silica, and magnesium stearate.

Appearance of Desmopresina Teva and packaging contents

White, biconvex, round tablets with the inscription ‘D’, scored and marked with ‘0.2’ on one side and smooth on the other.

The score is only for breaking the tablet if it is difficult to swallow whole.

They are packaged in OPA/Alu/PVC blisters.

Each package contains 10, 15, 30, 50 (hospital pack), 60, 90, 100, and 200 (2 x 100) tablets.

Only some package sizes may be commercially available.

Marketing authorization holder

TEVA PHARMA, S.L.U.

Anabel Segura 11 Edificio Albatros B 1st floor

28108 Alcobendas, Madrid

Responsible for manufacturing:

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

Debrecen H-4042, (Hungary)

or

Pharmachemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

GERMANY:Desmopressin-TEVA 0.2 mg Tabletten

BELGIUM:Desmopressine TEVA 0.2 mg film-coated tablets

BULGARIA:MIRAM 0.2 mg tablets

DENMARK:Desmopressin Teva0.2 mg tablets

SPAIN:Desmopresina Teva 0.2 mg tablets EFG

NETHERLANDS:Desmopressine-acetaat Teva 0.2 mg tablets

PORTUGAL:Desmopressina Teva0.2 mg tablets

This leaflet has been approved inJune 2024

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71385/P_71385.html