WETIRIN 0.2 mg TABLETS

Introduction

Leaflet: Information for the patient

Wetirin 0.2 mg tablets

Desmopressin

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Wetirin and what is it used for
2. What you need to know before taking Wetirin
3. How to take Wetirin
4. Possible side effects
5. Storage of Wetirin

1. Package contents and additional information

1. What is Wetirin and what is it used for

Wetirin contains desmopressin, a structural analogue of the natural pituitary hormone arginine vasopressin. Desmopressin belongs to the group of antidiuretic hormone (vasopressin) analogues, which temporarily reduces the amount of urine produced by the body.

Wetirin is used to treat central diabetes insipidus (continuous thirst and continuous elimination of very diluted urine) and primary nocturnal enuresis (urinary incontinence at night) in patients over 5 years of age with normal urine concentration capacity.

2. What you need to know before taking Wetirin

Do not take Wetirin

• if you are allergic to the active substance or to any of the other components of this medication (listed in section 6),
• if you have habitual or psychogenic polydipsia (excessive prolonged thirst or emotional/psychological origin),

• if you have heart failure and other conditions that require treatment with diuretics (medications that increase urine secretion),
• if you have moderate to severe renal impairment,
• If you have known hyponatremia (low sodium levels in the blood)
• If you have a syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

If you have primary nocturnal enuresis, be careful to restrict fluid intake, not drinking between 1 hour before and 8 hours after administration.

Treatment without simultaneous reduction of water intake may cause water retention and/or decreased sodium levels in the blood, accompanied by symptoms and signs of alarm (headache, nausea/vomiting, weight gain, and in severe cases, convulsions). See section 4.

Special care should be taken to avoid decreased sodium levelsin the following cases:

• Generalized infections, fever, and gastroenteritis(inappropriate antidiuretic hormone secretion syndrome).
• Risk of increased pressure inside the cranial cavity.
• Imbalance in water and mineral salt content.

• Treatmentwith medications that may cause diabetes insipidus, such as antidepressants (e.g., amitriptyline), selective serotonin reuptake inhibitors (e.g., fluoxetine), chlorpromazine, and carbamazepine.

• Treatmentwith non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid.

Use of other medications and Wetirin

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take other medications.

Wetirin may interact with medications that can cause diabetes insipidus, such as antidepressants (e.g., amitriptyline), selective serotonin reuptake inhibitors (e.g., fluoxetine), chlorpromazine, and carbamazepine, as well as some antidiabetic medications from the sulfonylurea group, especially chlorpropamide.

Non-steroidal anti-inflammatory drugs may induce water retention and decreased sodium levels in the blood.

Caution should be exercised if you are being treated with loperamide (a medication used to treat diarrhea), as it may increase the risk of water retention and decreased sodium levels in the blood.

Use of Wetirin with food and beverages

It is recommended to take Wetirin with some food (not rich in fat).

It is recommended not to drink liquids with Wetirin.

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.

There are no sufficient clinical data to support its use during pregnancy. Animal studies have not shown a potential fetal risk with the administration of desmopressin.

Desmopressin, although in small amounts, passes into breast milk, so if it needs to be administered to a breastfeeding woman, it is recommended to substitute breastfeeding.

Driving and using machines

Wetirin does not affect the ability to drive or use machines.

Important information about excipients:

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

3. How to take Wetirin

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

Usual dose

Central diabetes insipidus: The doctor will adjust the dose individually.

The recommended initial dose is 0.1 mg (one 0.1 mg Wetirin tablet) taken three times a day. The doctor will then adjust the dose according to each patient's response.

The maintenance dose usually ranges between 0.1 mg and 0.2 mg of Wetirin (one or two 0.1 mg Wetirin tablets) three times a day.

Normally, the total daily dose ranges from 0.2 mg to 1.2 mg of desmopressin.

Primary nocturnal enuresis:

The recommended initial dose is 0.2 mg of Wetirin at bedtime. If this is not sufficient, the dose can be increased to 0.4 mg of Wetirin.

It is essential to control fluid intake.

In case of observing symptoms or signs of water retention and/or decreased sodium levels in the blood (headache, nausea, and vomiting, weight gain, and in severe cases, convulsions), treatment should be interrupted until the patient has recovered. Once treatment is restarted, fluid intake will be strictly controlled.

Swallow the tablet, preferably with a glass of water. It is best to take it with some food. The tablet should be taken three times a day, preferably with meals in the case of central diabetes insipidus. If you are being treated for primary nocturnal enuresis, it is recommended to take the tablet at bedtime with dinner, once a day.

If you think the effect of Wetirin is too strong or too weak, tell your doctor or pharmacist.

Duration of treatment

Your doctor will indicate the duration of your treatment with Wetirin. Do not stop treatment before completing it, as it may not have the expected effect.

Treatment for primary nocturnal enuresis will last for 3 months. Then, the doctor will assess the need to continue treatment, and if so, it will be restarted after at least a week of rest.

If you take more Wetirin than you should

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone (91) 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the leaflet to the healthcare professional.

If an overdose occurs, the duration of action of desmopressin will be prolonged, and some symptoms will be those consequent to water retention and/or decreased sodium levels in the blood, with headache, nausea, and vomiting, weight gain, and in severe cases, convulsions. It is recommended to interrupt treatment, restrict fluid intake, and provide symptomatic treatment if necessary.

If you forget to take Wetirin

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

If you stop treatment with Wetirin

Do not stop treatment with this medication before completing it, as it may not have the expected effect. Only change or stop treatment if your doctor indicates so.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Frequent, (may affect up to 1 in 10 patients):Headache.

Uncommon, (may affect up to 1 in 100 patients):Mood changes, aggression, abdominal pain, nausea, vomiting, diarrhea, symptoms in the bladder and urethra, peripheral edema, fatigue.

Rare, (may affect up to 1 in 1000 patients):Anxiety symptoms, nightmares, mood changes, somnolence, hypertension, irritability.

Frequency not known: Anaphylactic reaction, hyponatremia, dehydration, hypernatremia, abnormal behavior, emotional disorder, depression, hallucinations, insomnia, attention disorders, psychomotor hyperactivity, convulsions, epistaxis, allergic dermatitis, exanthema, sweating, urticaria.

Due to decreased sodium levels in the blood due to water retention as a consequence of treatment, along with reduced fluid intake, headache, nausea, vomiting, decreased sodium levels, weight gain, and in severe cases, convulsions may occur.

Reporting of side effects:

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

5. Storage of Wetirin

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

Store it in its original packaging, at a temperature below 25°C, and in a dry place. Do not remove the desiccant from the cap.

Do not use this medication after the expiration date stated on the packaging, after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6.

Composition of Wetirin 0.2 mg tablets:

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

• The other components are: lactose monohydrate, potato starch, povidone, and magnesium stearate.

Appearance of the product and package contents

The tablets are white, round, and convex, with a unique mark on one face that reads "0.2 milligrams".

They are presented in 30 ml high-density polyethylene bottles with a polypropylene cap and a child-resistant closure. A silica gel capsule is included in the cap, which acts as a desiccant.

The bottle contains 30 tablets.

Marketing Authorization Holder

FERRING, S.A.U

C/ del Arquitecto Sánchez Arcas nº3, 1º

28040 Madrid

Spain

Manufacturer

FERRING GmbH

Wittland 11,

D-24109 Kiel

Germany

Date of the last revision of the leaflet:November 2020

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