Desmopressin Teva 0.2 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Desmopressin Teva 0.2 mg tablets EFG

Read all of this 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, 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, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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 Desmopressin Teva is and what it is used for

The active ingredient that makes the tablet work (the active substance) is desmopressin. Desmopressin is an antidiuretic, which reduces the amount of urine produced by the kidneys.

Desmopressin Teva is used to treat:

• A chronic condition called central diabetes insipidus, which causes excessive thirst and the continuous production of large amounts of urine. Important: Do not confuse with diabetes mellitus (sugar diabetes).
• Enuresis in children (involuntary nighttime urination) over 5 years of age.
• Frequent need to urinate during the night in adults (nocturia).

2. What you need to know before taking Desmopresin Teva

Do not take Desmopresin Teva

• if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if you drink large amounts of fluids,
• if you have heart problems or other conditions requiring treatment with diuretics (tablets that increase urine output),
• if you have kidney impairment,
• if you know you have low sodium levels in the blood (hyponatremia),
• if you have the “Syndrome of Inappropriate Antidiuretic Hormone Secretion” (SIADH),
• if you have von Willebrand disease type IIB (an inherited bleeding disorder),
• if you have a rare blood disorder called thrombotic thrombocytopenic purpura (TTP).

Warnings and precautions

Talk to your doctor or pharmacist before taking Desmopresin Teva:

• Regarding your fluid intake. You must keep your fluid intake to a minimum from 1 hour before taking a tablet until 8 hours after each dose.
• If you are elderly.
• If you have a medical condition causing fluid and/or electrolyte imbalance in the body, such as an infection, fever, or stomach upset.
• If you are at risk of increased pressure in the brain.
• If you have a severe bladder problem or difficulties urinating.
• If you have cystic fibrosis, as your doctor will need to monitor your blood sodium levels.
• If you suffer from asthma, epilepsy, or migraine.

Taking Desmopresin Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• Medicines that increase the risk of water retention, 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),
  • pain and/or anti-inflammatory medicines called non-steroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, ibuprofen.

• Medicines that reduce the absorption of desmopressin:

  • dimethicone (used to treat symptoms caused by intestinal gas).

Taking Desmopresin Teva with food and drinks

• Do not take Desmopresin Teva with food, as this may reduce the effect of the tablets. To ensure correct dosing, it is very important that the time interval between taking the tablet and the next meal remains consistent.
• Before starting treatment with this medicine, your doctor should give you advice about fluid intake.
• When this medicine is used for enuresis or nocturia, minimize fluid intake from 1 hour before taking a tablet until 8 hours after each dose.
• Excessive fluid intake may lead to fluid retention, which dilutes salt in the body. This can occur with or without warning signs or symptoms, including unusual or prolonged headache, nausea or vomiting, unexplained weight gain, and in severe cases, seizures and loss of consciousness. If you experience any of these symptoms, stop taking Desmopresin and contact your doctor immediately.

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.

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

Driving and using machines

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

Desmopresin Teva contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Desmopresin Teva

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

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

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 depending on your response to symptoms.

• Nocturnal enuresis (involuntary nighttime urination)

Children over 5 years of age: 200 micrograms (0.2 mg) before bedtime. Your doctor may increase the dose up to 400 micrograms (0.4 mg) at bedtime, depending on the response to enuresis. The need for continued treatment is usually reviewed every three months by introducing a treatment-free period of at least one week.

• Frequent need to urinate at night (nocturia)

Treatment of increased nighttime urination with desmopressin in adults (nocturia) should be initiated and monitored by specialists experienced 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) at weekly intervals. Before starting treatment, urine output should be measured. If nocturia does not improve after four weeks, consult your doctor, as treatment should be discontinued.

Elderly patients (over 65 years of age): treatment of nocturia is not recommended in the elderly. If your doctor decides to treat you, blood sodium levels should be measured before starting treatment and again three days after initiation, as well as whenever the dose is increased or at any time deemed necessary by your doctor.

When using this medicine for enuresis or nocturia, fluid intake should be reduced starting at least 1 hour before taking a tablet and continuing for up to 8 hours after a dose.

Split the tablets in half or swallow them whole. The score line is only intended to facilitate administration if you have difficulty swallowing the whole tablet.

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

If you take more Desmopresin Teva than you should

An 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 Desmopresin Teva than prescribed, contact your doctor, pharmacist, or go to the nearest hospital.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91-562 04 20, indicating the medicine and the amount ingested.

If you forget to take Desmopresin Teva

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

If you stop taking Desmopresin Teva

You should only change or stop treatment if instructed to do so by your doctor.

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 experiences them.

Stop treatment and contact your doctor immediately if the following occur:

• Various or severe allergic symptoms or fluid retention. These include the side effects listed below marked with an asterisk (*).
• hypersensitivity reactions such as skin rash, itching, fever, swelling of the mouth, tongue, or airways causing difficulty swallowing or breathing problems.

Adverse 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 blood*
• dizziness*
• increased blood pressure
• nausea*, abdominal pain*, diarrhea, constipation, vomiting*
• urinary problems (such as passing small amounts of urine frequently, strong need to urinate)
• fluid retention
• fatigue

Uncommon (may affect up to 1 in 100 people)

• insomnia
• drowsiness, abnormal skin sensations
• visual disturbances
• vertigo*
• palpitations
• decrease in blood pressure when standing up from a lying position
• difficulty breathing
• gastrointestinal discomfort, e.g. heartburn, flatulence, bloating
• sweating, itching, skin rash, urticaria
• muscle spasms, muscle pain
• urinary symptoms
• feeling unwell*
• chest pain
• flu-like symptoms
• weight gain*
• changes in liver function
• low potassium levels in blood

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

• confusion*
• skin allergic reaction

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

• seizures*
• loss of consciousness*
• In the treatment of central diabetes insipidus, dehydration, elevated blood sodium levels, and muscle weakness may occur.

Adverse 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 of age, nightmares and mood changes may also occur
• drowsiness
• increased blood pressure
• irritability

Frequency not known (cannot be estimated from available data)

• low sodium levels in blood*
• abnormal behavior, emotional disorder, depression, hallucinations, insomnia
• attention disorders, hyperactivity, seizures*
• nosebleeds
• skin allergic 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 not listed in this leaflet. You may also report them via the Spanish Pharmacovigilance System for Human Medicines website: 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 which is stated on the packaging, blister, or bottle after "EXP". The expiry date refers to the last day of the month indicated.

Blister: Do not store above 30°C.

Bottle: Do not store above 30°C; keep the bottle tightly closed to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desmopresin Teva

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

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

Appearance of Desmopresin Teva and contents of the pack

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

The score line is provided only to facilitate tablet splitting if you have difficulty swallowing the whole tablet.

They are packaged in OPA/Alu/PVC blisters.

Each pack contains 10, 15, 30, 50 (hospital pack), 60, 90, 100 and 200 (2x100) tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder

TEVA PHARMA, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid, Spain

Manufacturer:

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

Debrecen H-4042, (Hungary)

or

Pharmachemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

The Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

GERMANY: Desmopressin-TEVA 0.2 mg Tabletten

BELGIUM: Desmopressine TEVA 0.2 mg filmomhulde tabletten

BULGARIA: MIRAM 0.2 mg tablets

DENMARK: Desmopressin Teva 0.2 mg tabletter

SPAIN: Desmopresina Teva 0.2 mg comprimidos EFG

NETHERLANDS: Desmopressine-acetaat Teva 0.2 mg, tabletten 0.2 mg

PORTUGAL: Desmopressina Teva 0.2 mg comprimidos

This leaflet was approved in June 2024

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

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71385/P_71385.html