Prospect: Information for the Patient

Gamavan 360micrograms/mL oral solution

(desmopressin)

Read this prospect carefully before starting to take this medication, 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 medication has been prescribed only for you or your child and should not be given to others, even if they have the same symptoms as you or your child, as it may harm them.
• If you or your child experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section4.

1.What is Gamavan 360micrograms/mL oral solution and what it is used for

2.What you need to know before starting to take Gamavan 360micrograms/mL oral solution

3.How to take Gamavan 360micrograms/mL oral solution

4.Possible adverse effects

5.Storage of Gamavan 360micrograms/mL oral solution

6.Contents of the package and additional information

The active ingredient of this medication is called desmopresina. Desmopresina is very similar to a substance that is produced naturally in the body (the hypophyseal hormone vasopresina), which temporarily reduces the amount of urine produced by the body. This medication is intended for oral use only.

Desmopresina is used to treat:

• Central diabetes insipidus, a disease that is characterized by extreme thirst and continuous production of large volumes of very diluted urine as a result of insufficient production of the vasopresina hormone.

• Primary nocturnal enuresis (urinary incontinence at night) in patients over 5 years old with normal ability to concentrate urine.

Do not take Gamavan:

• if you areallergic(hypersensitive) todesmopressinor to any of theother componentsof this medication (listed in section6),
• if youdrinklarge amounts of liquid (present habitual or psychogenic polydipsia),
• if you takediureticsthat increase urine production,
• if you haveheart problems,
• if you are predisposed to or havelow sodium levels in the blood (hyponatremia), inability to reduce fluid intake, for example, in memory disorders,
• if you havekidney insufficiency,
• if you have thesyndrome of inappropriate antidiuretic hormone secretion (SIADH).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gamavan.

When taking desmopressin, avoid excessive fluid intake as it may cause fluid retention in the body and/or a decrease in sodium levels in the blood, with or without side effects (see section4. Possible side effects).

Special care should be taken with desmopressin to avoid fluid retention in the body and a decrease in sodium levels in the blood in the following cases:

• if you are an elderly person
• if you have any medical condition that causes aimbalance of water and/or electrolytesin the body, such as infection, fever, or stomach upset If you have aserious bladder problem or an alteration of urine evacuation
• if you haveasthma, epilepsyandmigraines
• if you havekidney insufficiency and/or cardiovascular disease.In the case ofchronic kidney insufficiency, the antidiuretic effect of Gamavan would be lower than usual.

Other medications and Gamavan

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

• tricyclic antidepressants or SSRIs(used to treat depression),
• carbamazepine(used to treat epilepsy),
• chlorpromazine(used to treat psychosis or schizophrenia),
• pain and/or anti-inflammatory medicationsdenominated non-steroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, ibuprofen, or acetylsalicylic acid,
• loperamide(used to treat diarrhea),
• diuretics.

These medications increase the risk of fluid retention, which dilutes the salt in the body.

• Dimethicone (used in the treatment of intestinal gas), as it reduces the absorption of desmopressin.

Taking Gamavan with food and drinks

See section3 “How to take”.

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.

It is preferable to avoid taking Gamavan during pregnancy.

Desmopressin passes into breast milk. If you are being treated with desmopressin, you should stop breastfeeding.

Driving and operating machinery

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

Important information about some of the components of Gamavan:

This medication may cause allergic reactions (possibly delayed) because it contains methyl-parahydroxybenzoate sodium and propyl-parahydroxybenzoate sodium.

This medication contains less than 23 mg of sodium (1 mmol) per ml; it is essentially “sodium-free”.

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

In low doses, Gamavan may be affected by food intake. If you notice that Gamavan is less effective, you must take the medication without food before increasing the dose.

When taking this medication for nocturnal urinary incontinence, reduceto a minimum the consumption of liquidsfrom1hour beforetaking the Gamavan dose anduntil 8hours after.

Treatment of central diabetes insipidus:

Adults and children:Your doctor will prescribe the most suitable dose for your case. Theinitial doserecommended is 0.25ml (90micrograms) three times a day. Subsequently, the doctor will adjust the dose according to the response of each patient. Therecommended daily doseis between 0.5ml (180micrograms) and 3ml (1080micrograms) of Gamavan. Themaintenance dosevaries between 0.25 and 0.5ml (90– 180micrograms) of Gamavan three times a day.

It is essential to note if symptoms of fluid retention in the body and/or decreased sodium in the blood (see section4: Possible adverse effects) appear, in which case the treatment should be interrupted to change the dose.

Nocturnal enuresis primary (nocturnal urinary incontinence) in patients over 5years:

Adults and children:The recommended initial dose is 0.5ml (180micrograms) of Gamavan one hour before bedtime. The dose can be increased up to 1ml (360micrograms) of Gamavan if the initial dose is not sufficient. The need to continue treatment is usually checked every three months by introducing a period without treatment of at least one week.

Instructions for use:

1. Open the bottle (the seal breaks on the first opening).

2. Insert the oral syringe into the dispenser and turn the bottle to fill it with the dose to be administered.

3. Remove the oral syringe from the bottle and check that the syringe bottom presents the correct amount.

4. Place the syringe in the mouth and administer the dose.

5. Rinse with water after each use and close the bottle. Keep the bottle in the outer packaging to protect it from light.

If you take more Gamavan than you should

If you take moreGamavanthan prescribed, contact your doctor or pharmacist immediately.

A overdose may prolong the effect of desmopressin and increase the risk of fluid accumulation in the body or decreased sodium levels in the blood. Symptoms may include headache, nausea, and vomiting, weight gain, and in severe cases, seizures. It is recommended to interrupt treatment, restrict liquid intake, and administer symptomatic treatment if necessary.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Gamavan

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

If you interrupt treatment with Gamavan

Do not stop taking Gamavan before completing treatment, as it may not have the expected effect. Only change or interrupt treatment if your doctor indicates it.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following symptoms, stop taking Gamavan and consult a doctor or go immediately to a hospital:

Unknown frequency(cannot be estimated from available data)

• symptoms offluid retentionin the body, such as particularly strong or prolonged headache, dizziness, feeling or being sick, weight gain, and in severe cases, convulsions or loss of consciousness (hyponatremia)
• allergic reactionssuch as rash, itching, fever, swelling of the lips, face, throat, or tongue that causes difficulty swallowing or breathing
• symptoms of sodium accumulation in the body such as confusion, muscle contractions or spasms (hypernatremia)

Inform your doctor or pharmacistif you observe any of these other side effects:

Frequent (can affect up to 1 in 10 people)

• abdominal pain, nausea, high blood pressure, diarrhea, constipation, urinary and kidney problems, swelling,
• headache

Not frequent(can affect up to 1in 100people)

• sudden and exaggerated mood changes, aggression, urinary and kidney problems, swelling of hands and feet, fatigue

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

• anxiety, nightmares, mood changes, drowsiness, high blood pressure, irritability

Unknown frequency (cannot be estimated from available data)

• loss of consciousness, weakness, convulsions, emotional disorders, abnormal behavior, depression, hallucinations (seeing, hearing, or feeling things that are not present), insomnia, attention disorders, restlessness, nasal bleeding, sweating, skin eruptions, urticaria, skin allergies.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side 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.

This medication does not require special storage conditions.

Store in the original packaging.

After the first opening, store below 25°C for a maximum of 8 weeks.

Do not use this medication after the expiration date that appears on the packaging or label after CAD or EXP. The expiration date is the last day of the month indicated.

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

Composition of Gamavan

• The active principle is desmopressin. Each milliliter of the oral solution contains 360 micrograms of desmopressin (in the form of acetate).
• The other components are:

• methyl-parahydroxybenzoate sodium (E-219)
• propyl parahydroxybenzoate sodium (E-217)
• hydrochloric acid (for pH adjustment)
• purified water

Appearance of the product and contents of the packaging

Gamavan is a transparent solution included in an amber glass bottle sealed with a plastic dispenser, provided with a screw-top also made of plastic. The bottle contains 15 milliliters of solution. The bottle is packaged in a cardboard box with a 1.5 milliliter dosing syringe. The syringe is graduated from 0 to 1.5 milliliters with divisions every 0.1 milliliters. The graduation corresponding to the doses of 0.25 milliliters, 0.5 milliliters, and 1.0 milliliters is specifically marked.

Holder of the marketing authorization

GP-Pharm, S.A.

Industrial Estate Els Vinyets – Els Fogars, sector 2

Carretera Comarcal C244, Km 22,

08777 – Sant Quintí de Mediona (Barcelona) SPAIN

Responsible for manufacturing

Laboratorio Reig Jofré S.A.,

Gran Capitàn nº 10,

08970 Sant Joan Despí – Barcelona

Spain

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

Last review date of this leaflet: May 2021

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