Prospect: information for the patient

Variargil 40mg/ml oral drops in solution

Alimemazine

Read this prospect carefully before starting to take the 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, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1.What is Variargil and what it is used for

2.What you need to know before starting to take Variargil

3.How to take Variargil

4.Possible adverse effects

5.Storage of Variargil

6.Contents of the package and additional information

Variargil is an oral solution for administration that contains 40 mg/ml of alimemazina.

Alimemazina is an antihistamine that is used for the symptomatic relief of allergic manifestations: seasonal or perennial allergic rhinitis, allergic conjunctivitis, angioedema, and mild urticaria.

Do not take Variargil

If you are allergic (hypersensitive) to the active ingredient, to phenothiazines (chlorpromazine), or any of the other components of Variargil (listed in section 6)

- In children under 2 years

If you have liver or kidney disease.

- If you have prostate hypertrophy (enlargement of the prostate), closed-angle glaucoma, Parkinson's disease, epilepsy, hypothyroidism, phaeochromocytoma, or myasthenia gravis (muscle disease)

- Children over 2 years with severe dehydration or acute diseases

Children over 2 years with a history of nocturnal apnea (respiratory arrest) or family history of sudden infant death syndrome.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Variargil:

- If you are exposed to the sun, as photosensitivity reactions may occur. You should avoid prolonged exposure to the sun.

- If you are elderly, as adverse effects may occur more frequently.

- If you have severe vomiting.

- If you observe an aggravation of allergic symptoms (difficulty breathing, skin lesions, edema), it is recommended to consult your doctor as it may be necessary to interrupt treatment

• If you have any cardiovascular condition, as alimemazine may cause hypotension and tachycardia.

Other medicines and Variargil

Inform your doctor or pharmacist if you are taking or have taken recently or may take any other medicine.

The simultaneous use with medicines for the treatment of diarrhea or stomach acid may reduce the effects of Variargil.

In case you are being treated with medicines to reduce blood pressure, Variargil may increase the effect of these.

Do not associate with CNS depressants (hypnotics, sedatives, anxiolytics) due to the risk of respiratory depression.

Administration of Variargil with food and drinks

You should not take alcoholic beverages during treatment.

Pregnancy, breastfeeding, and fertility

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

As a general rule, it is not recommended to use during the first trimester of pregnancy or during the two weeks before delivery.

Alimemazine is excreted in breast milk, so women in the lactation period should consult their doctor before using this medicine.

Driving and operating machinery

Variargil may cause drowsiness, especially at the beginning of treatment, which could affect your ability to drive and/or operate machinery. Patients should avoid operating hazardous machinery, including cars, until they know how they tolerate the medicine.

Variargil contains saccharose, and macrogolglycerol hydroxystearate

This medicine contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medicine. It may cause tooth decay.

This medicine contains less than 23 mg of sodium (1 mmol) per drops; it is essentially "sodium-free".

This medicine may cause stomach discomfort and diarrhea because it contains Macrogolglycerol hydroxystearate.

Follow exactly the administration instructions for this medication contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

To obtain the correct dosage, the bottle has a built-in dropper stopper. Each drop is equivalent to

1.25 mg of alimemazine

This medication is administered orally. The recommended dose is as follows:

-

-Adults and children over 12 years old: 8 drops (10 mg) two or three times a day; maximum daily dose 24 drops (30 mg of alimemazine)

-Use in elderly patients: 8 drops (10 mg) one or two times a day; maximum daily dose 16 drops (20 mg of alimemazine)

-Use in children over 2 years old: 2-4 drops (2.5 –5 mg) two or three times a day, which means a maximum daily dose of 12 drops (15 mg of alimemazine)

It is recommended to administer the higher dose before going to bed.

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

If you take more Variargil than you should

You must consult your doctor or pharmacist immediately.

The symptoms of overdose may be: drowsiness, fainting, excitement, euphoria, hallucinations, or convulsions, and even sudden death.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Variargil

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

Like all medications, this medication may produce adverse effects, although not all people may experience them. The most frequent, although mild, adverse effects are drowsiness, somnolence, and dry mucous membranes, especially at the beginning of treatment.

In rare cases, general adverse effects such as skin redness, itching, sensitivity to light, excessive sweating, and chills may occur.

Other adverse effects that may occur include blood-related alterations, cardiovascular (palpitations, tachycardia, hypotension), neurological (dizziness, confusion, problems with concentration or movement coordination, especially in elderly patients; insomnia, nervousness, or irritability, especially in children) or eye-related (vision accommodation problems, pupil dilation), liver function (yellow discoloration of skin and mucous membranes, usually temporary), or kidney function (urine retention, especially at high doses and in elderly patients).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: 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.

No special storage conditions are required.

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.

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

Composition of Variargil

- The active principle is alimemazina as tartrate salt in an amount of 40 mg per ml. One drop is equivalent to 1.25 mg of alimemazina base.

- The other components are saccharose, peppermint aroma, propylene glycol, citric acid, glycerol (E-422), sodium saccharin, and macrogolglycerol hydroxystearate and purified water c.s.

Appearance of the product and contents of the packaging

It is presented in a 30 ml bottle with a dropper cap.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Logogen S.A. Pharmaceutical Laboratories

San Rafael 3, 28108-Alcobendas (Madrid)

Responsible for manufacturing

ITALFARMACO S.A.

San Rafael 3, 28108-Alcobendas (Madrid)

Last review date of this leaflet: July 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/.