Patient Information Leaflet: Package Insert

Wetirin 0.2 mg Tablets

Desmopressin

Read 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Table of Contents:

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

6.Contents of the pack and additional information

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

Wetirin is used to treat central diabetes insipidus (persistent thirst and continuous production of very diluted urine) and primary nocturnal enuresis (bedwetting) in patients over 5 years old with normal urine concentration ability.

Do not take Wetirin

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

• if you have heart failureand other conditions that require treatment with diuretics (medications that increase urine production),
• if you havemoderate to severe kidney insufficiency,
• if you have known hyponatremia (low sodium levels in the blood),
• if you have a syndrome of inadequate secretion of ADH (antidiuretic hormone).

Warnings and precautions

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

if you haveprimary nocturnal enuresis, take special care to restrict fluid intake, not drinking between 1 hour before and 8 hours after administration.

A treatment without simultaneous reduction of water intake may cause water retention and/or decreased sodium levels in the blood, accompanied or not by symptoms and signs of alarm (headache, nausea/vomiting, weight gain, and in severe cases, seizures). See section 4.

Special care should be taken toavoid decreased sodium levels in the blood in the following cases:

• Generalized infections, fever, and gastroenteritis (syndrome of inappropriate ADH secretion).
• Increased intracranial pressure risk.
• Imbalance of water and electrolyte content.

• Treatmentwith concomitant medications thatmay cause diabetes insipidusby themselves, such as: antidepressants of the type: tricyclic antidepressants, for example, amitriptyline, selective serotonin reuptake inhibitors, for example, fluoxetine, chlorpromazine, and carbamazepine.

• Treatmentwith concomitantAINEs (nonsteroidal anti-inflammatory drugs)such as acetylsalicylic acid.

Use of other medications and Wetirin

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

Wetirin may interact with medications that may cause diabetes insipidus by themselves, such as: antidepressants of the type: tricyclic antidepressants, for example, amitriptyline, selective serotonin reuptake inhibitors, for example, fluoxetine, chlorpromazine, and carbamazepine, as well as some antidiabetic drugs of the sulfonilurea group, especially chlorpropamide.

Nonsteroidal anti-inflammatory drugs may induce water retention and/or 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 fats).

It is recommended not to ingest liquids with Wetirin.

Pregnancy, breastfeeding, and fertility

if you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

There are no sufficient clinical data to evaluate 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 in the case of having to administer it to a woman breastfeeding, it is recommended to substitute breastfeeding.

Driving and operating machinery

Wetirin does not affect the ability to drive or operate machinery.

Important information about excipients:

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

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

Usual dose

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

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

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

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

Primary nocturnal enuresis:

The initial recommended dose is 0.2 mg of wetirin at bedtime. If this is not sufficiently active, 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 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 reinstated, fluid intake will be strictly controlled.

Swallow the tablet, preferably with a glass of water. It is better to ingest some food with the tablet. 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 nocturnal enuresis, it is recommended to take the tablet at bedtime with dinner, once a day.

If you estimate that the action of Wetirin is too strong or too weak, inform your doctor or pharmacist.

Treatment duration

Your doctor will indicate the duration of your treatment with Wetirin. Do not discontinue treatment prematurely, as this may not have the desired effect.

Treatment for nocturnal enuresis will be prolonged for 3 months. Then, your doctor will evaluate the need to continue treatment and, if so decided, treatment will be reinstated, maintaining at least a week of rest.

If you take more Wetirin than you should

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

In case of overdose, the duration of action of desmopresina will be prolonged, and some symptoms will be the consequences of water retention and/or decreased sodium 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 forgot to take Wetirin

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

If you interrupt treatment with Wetirin

Do not discontinue treatment with this medication before completing it, as this may not have the desired effect. You should only change or discontinue treatment if your doctor instructs you to do 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.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

Rarely, (may affect up to 1 in 100 patients):Mood changes, aggression, abdominal pain, nausea, vomiting, diarrhea, urinary and urethral symptoms, peripheral edema, fatigue.

Infrequent, (may affect up to 1 in 1000 patients):Anxiety symptoms, nightmares, mood swings, drowsiness, hypertension, irritability.

Unknown frequency: Anaphylactic reaction, hyponatremia, dehydration, hypernatremia, abnormal behavior, emotional disorder, depression, hallucinations, insomnia, attention alteration, hyperactivity, seizures, epistaxis, allergic dermatitis, exanthema, sweating, urticaria.

Due to the decrease in sodium in the blood caused by water retention as a result of treatment combined with a reduction in fluid intake, headache, nausea, vomiting, decreased sodium, weight gain, and in severe cases, seizures may occur.

Reporting Adverse Effects:

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

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

Store in the 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 appearing on the packaging, after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Wetirin 0.2 mg tablets:

- The active ingredient is desmopressin acetate. Each tablet contains0.2 mg of desmopressin acetatecorresponding to 0.178 mg of desmopressin base.

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

Appearance of the product and contents of the package:

The tablets are white, round, and convex, with a unique mark on one face that says “0.2 milligrams”.

They are presented in 30 ml high-density polyethylene bottles with polypropylene stoppers and child-resistant closures. The bottle includes a silica gel capsule in the stopper that acts as a desiccant.

The bottle contains 30 tablets.

Holder ofthe Marketing Authorizationfor Commercialization:

FERRING, S.A.U

C/ del Arquitecto Sánchez Arcas nº3, 1º

28040 Madrid

Spain

Responsible for Manufacturing:

FERRING GmbH

Wittland 11,

D-24109Kiel

GERMANY

Last review date of the prospectus:November 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/