Gamavan 360 micrograms/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Gamavan 360 micrograms/ml oral solution

(desmopressin)

Read the entire leaflet carefully before you start taking this medicine, as 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 or your child only and must not be given to other people, even if they have the same symptoms as you or your child, as it may harm them.
• If you or your child 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 Gamavan 360 micrograms/ml oral solution is and what it is used for
2. What you need to know before taking Gamavan 360 micrograms/ml oral solution
3. How to take Gamavan 360 micrograms/ml oral solution
4. Possible side effects
5. How to store Gamavan 360 micrograms/ml oral solution
6. Contents of the pack and other information

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

The active substance in this medicine is called desmopressin. Desmopressin is very similar to a substance naturally produced in the body (the pituitary hormone vasopressin), which temporarily reduces the amount of urine produced by the body. This medicine is intended for oral use only.

Desmopressin is used to treat:

• Central diabetes insipidus, a condition characterized by extreme thirst and the continuous production of large volumes of very dilute urine due to insufficient production of the hormone vasopressin.

• Primary nocturnal enuresis (urinary incontinence during the night) in patients over 5 years of age who have a normal ability to concentrate urine.

2. What you need to know before taking Gamavan 360 microgram/ml oral solution

Do not take Gamavan:

• if you are allergic (hypersensitive) to desmopressin or to any of the other components of this medicine (listed in section 6),
• if you drink exceptionally large amounts of liquid (have habitual or psychogenic polydipsia),
• if you are taking medicines that increase urine production (diuretics),
• if you have heart problems,
• if you have a predisposition to or suffer from low sodium levels in the blood (hyponatremia), or inability to reduce fluid intake, for example, in memory disorders,
• if you have renal insufficiency,
• if you have the “syndrome of inappropriate antidiuretic hormone secretion” (SIADH).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Gamavan.

When taking desmopressin, avoid excessive fluid intake, as this may cause fluid retention in the body and/or a decrease in blood sodium levels, with or without side effects (see section 4. Possible side effects).

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

• If you are elderly
• If you have a medical condition causing water and/or electrolyte imbalance in the body, such as infection, fever, or gastrointestinal discomfort
• If you have a severe bladder problem or impaired urination
• If you have asthma, epilepsy, or migraines
• If you have renal insufficiency and/or cardiovascular disease. In cases of chronic renal failure, the antidiuretic effect of Gamavan may be lower than usual.

Other medicines and Gamavan

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, 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 medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, ibuprofen, or acetylsalicylic acid,
• loperamide (used to treat diarrhea),
• diuretics.

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

• Dimethicone (used to treat intestinal gas), because it reduces the absorption of desmopressin.

Taking Gamavan with food and drink

See section 3 “How to take”.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is preferable to avoid taking Gamavan during pregnancy.

Desmopressin passes into breast milk. Your doctor will advise whether you should breastfeed your baby or continue treatment with desmopressin; you should not do both.

Driving and using machines

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

Important information about some of the components of Gamavan:

This medicine may cause allergic reactions (possibly delayed) because it contains sodium methylparahydroxybenzoate and sodium propylparahydroxybenzoate.

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

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

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

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

When taking this medicine for nocturnal urinary incontinence, reduce fluid intake to a minimum starting 1 hour before taking the dose of Gamavan and until 8 hours after.

Treatment of central diabetes insipidus:

Adults and children: Your doctor will prescribe the most suitable dose for your case. The recommended initial dose is 0.25 ml (90 micrograms) three times daily. Subsequently, your doctor will adjust the dose according to each patient's response. The recommended daily dose ranges from 0.5 ml (180 micrograms) to 3 ml (1080 micrograms) of Gamavan. The maintenance dose varies between 0.25 and 0.5 ml (90–180 micrograms) of Gamavan three times daily.

It is important to report any symptoms of fluid retention in the body and/or decreased sodium levels in the blood (see section 4: Possible side effects). In such cases, treatment must be discontinued and your doctor will adjust the dose.

Primary nocturnal enuresis (nocturnal urinary incontinence) in patients over 5 years of age:

Adults and children: The recommended initial dose is 0.5 ml (180 micrograms) of Gamavan one hour before bedtime. The dose may be increased up to 1 ml (360 micrograms) of Gamavan if the initial dose is insufficient. The need to continue treatment is normally assessed every three months by introducing a treatment-free period of at least one week.

Instructions for use:

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

2. Insert the oral syringe into the dispenser and turn the bottle upside down to fill it with the prescribed dose.

3. Remove the oral syringe from the bottle and check that the bottom of the plunger indicates the correct amount.

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

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

If you take more Gamavan than you should

If you take more Gamavan than prescribed, contact your doctor or pharmacist immediately.

An overdose may prolong the effect of desmopressin and increase the risk of water retention 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 discontinue treatment, restrict fluid intake, and provide symptomatic treatment if necessary.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Gamavan

Do not take a double dose to make up for a missed dose.

If you stop taking Gamavan

Do not stop taking Gamavan before completing the treatment, as it may not have the intended effect. Only discontinue or change treatment if instructed 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.

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

Frequency not known (cannot be estimated from available data)

• symptoms of fluid retention in the body, such as particularly severe or prolonged headache, dizziness, feeling sick or being sick, weight gain, and in severe cases, seizures or unconsciousness (hyponatremia)
• allergic reactions such as rash, itching, fever, swelling of the lips, face, throat, or tongue causing difficulty swallowing or breathing
• symptoms of sodium accumulation in the body such as confusion, muscle twitching or spasms (hypernatremia)

Inform your doctor or pharmacist if you notice any of these other adverse effects:

Frequent (may affect up to 1 in 10 people)

• abdominal pain, nausea, high blood pressure, diarrhoea, constipation, bladder and kidney problems, swelling,
• headache

Uncommon (may affect up to 1 in 100 people)

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

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

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

Frequency not known (cannot be estimated from available data)

• unconsciousness, weakness, seizures, emotional disorders, abnormal behaviour, depression, hallucinations (seeing, hearing or feeling things that are not present), insomnia, attention disorders, restlessness, nosebleeds, sweating, skin rashes, urticaria, skin allergies.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gamavan 360 microgram/ml oral solution

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

This medicine does not require special storage conditions regarding temperature.

Store in the original packaging.

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

Do not use this medicine after the expiry date stated on the container or label, following CAD or EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gamavan

• The active substance is desmopressin. Each ml of oral solution contains 360 micrograms of desmopressin (as acetate).

• The other components are:

• sodium methyl hydroxybenzoate (E-219)

• sodium propyl hydroxybenzoate (E-217)

• hydrochloric acid (for pH adjustment)

• purified water

Appearance of the product and contents of the container

Gamavan is a clear solution contained in an amber glass bottle closed with a plastic dispenser and a plastic screw cap. The bottle contains 15 ml of solution. The bottle is packaged in a cardboard box with a 1.5 ml dosing syringe. The syringe is graduated from 0 to 1.5 ml with markings every 0.1 ml. The graduations corresponding to the doses of 0.25 ml, 0.5 ml and 1.0 ml are specifically marked.

Marketing Authorization Holder

GP-Pharm, S.A.

Polígono Industrial Els Vinyets – Els Fogars, sector 2

Carretera Comarcal C244, Km 22,

08777 – Sant Quintí de Mediona (Barcelona) SPAIN

Manufacturer

Laboratorio Reig Jofré S.A.,

Gran Capitàn nº 10,

08970 Sant Joan Despí – Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: June 2025

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