Diertine 2 mg/ml gotas orales en soluciÓn

Label: Information for the User

Diertine 2 mg/ml Oral Drops in Solution

Dihydroergocristine, Mesilate

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Diertine contains the active ingredient mesylate of dihydroergocristine,a semisynthetic derivative of ergocristine, an alkaloid of ergot (Claviceps purpurea).

Diertine is used in adults for the treatment of symptoms of circulatory disorders in otorhinolaryngology (vertiginous syndrome).

Do not takeDiertine

• If you are allergic to dihydroergocristine mesylate, ergot alkaloids, or any of the other components of this medication (listed in section 6).
• If you are pregnant or breastfeeding.
• If you have a history and/or symptoms of severe psychotic disorder.
• If you have a history of fibrotic disorders (cardiac, pulmonary, pleural, peritoneal, retroperitoneal).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diertine if:

• You have liver or kidney problems.
• You have severe bradycardia (slow heart rate).
• You have low blood pressure or are taking medications to lower blood pressure.

This medication should not be used continuously or at doses higher than recommended, as it may cause fibrotic reactions (formation of fibrous tissue in some organs) and ergotism (characterized by symptoms such as tingling, spasms, cramps, or coldness in the extremities).

Children and adolescents

Diertine is not recommended for use in children and adolescents (under 18 years of age) due to the lack of information on the use of this medication in this age group.

Other medications and Diertine

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

Especially, inform your doctor if you are being treated with:

• Macrolide antibiotics (e.g. erythromycin, clarithromycin), tetracycline, medications for HIV infection (e.g. ritonavir, indinavir, nelfinavir, amprenavir, delavirdine, saquinavir, atazanavir, and efavirenz), or antifungal medications (e.g. ketoconazole, itraconazole, voriconazole), as they may increase the concentration of dihydroergocristine in the blood.
• Other ergot derivatives (such as ergotamine), as it increases the risk of toxicity (fibrosis and ergotism).
• Medications for high blood pressure, as dihydroergocristine may lower blood pressure.
• Medications that slow the heart rate (e.g. beta-blockers), as dihydroergocristine may cause bradycardia (slow heart rate).

Diertine with food, drinks, and alcohol

No incompatibility with food, drinks, or alcohol is known.

Pregnancy and lactationDiertine should not be taken during pregnancy or lactation.

If you are pregnant or breastfeeding, consult your doctor before using this medication.

Driving and operating machinery

The influence of Diertine on the ability to drive and operate machinery is negligible or insignificant.

Diertine contains propylene glycol (E-1520)

This medication contains 1037 mg of propylene glycol in each 20 drops of oral solution, equivalent to 1037 mg/ml.

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

Your doctor will decide what is the most suitable dose for you.

The recommended dose in adults is 2 mg (20 drops) three times a day, or 3 mg (30 drops) twice a day (morning and night).

It should be administered after meals.

Treatment Duration

The duration of this treatment is limited. Your doctor will inform you of the duration of your treatment with Diertine. Take exactly the prescribed dose and do not modify it without speaking with your doctor first.

If You Take More Diertine Than You Should

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 take more Diertine than recommended, you may experience a decrease in blood pressure, a decrease in heart rate, and confusion. You may also experience blood vessel spasms, with an increase in blood pressure followed by a sensation of coldness and tingling in the extremities.

If You Forget to Take Diertine

If you forget to take a dose of Diertine, take the next scheduled dose at the usual time. Do not take a double dose to compensate for the missed doses.

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

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

Frequent Adverse Effects:(may affect up to 1 in 10 people)

• Nausea, vomiting, loss of appetite, diarrhea.

• Orthostatic hypotension (decrease in blood pressure when changing position).
• Exanthematous eruptions on the skin.

Less Frequent Adverse Effects(may affect up to 1 in 100 people)

• Blurred vision.
• Nasal congestion.
• Headache, dizziness.
• Bradycardia (slow heart rhythm).
• Hot flashes.

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 Medicinal Products for Human Usehttps://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.

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Diertine

The active principle is dihydroergocristine mesilate.Each milliliter of oral solution (20 drops) contains 2 mg of dihydroergocristine mesilate.

The other components (excipients) are: propylene glycol (E-1520).

Appearance of the product and contents of the packaging

Amber glass bottle containing 50 ml of transparent and colorless oral solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tora Laboratories, S.L.U.

Avenida de Oporto, 60

28019 Madrid, Spain

Responsible for manufacturing

Farmasierra

Carretera de Irún km 26,200

San Sebastián de los Reyes

28700 Madrid

Spain

Last review date of this leaflet:February 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/