VARIARGIL 40mg/ml ORAL SOLUTION DROPS

Introduction

Patient Information Leaflet

Variargil 40mg/ml Oral Drops in Solution

Alimemazine

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

Contents of the Leaflet

1. What Variargil is and what it is used for
2. What you need to know before taking Variargil
3. How to take Variargil
4. Possible side effects
5. Storage of Variargil
6. Package contents and additional information

1. What Variargil is and what it is used for

Variargil is an oral solution containing 40 mg/ml of alimemazine.

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

2. What you need to know before taking Variargil

Do not take Variargil

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

• In children under 2 years of age

If you have liver or kidney disease.

• If you have prostatic hypertrophy (enlargement of the prostate), narrow-angle glaucoma, Parkinson's disease, epilepsy, hypothyroidism, pheochromocytoma, or myasthenia gravis (muscle disease)
• In children over 2 years of age with severe dehydration or acute illnesses

In children over 2 years of age with a history of apnea (breathing stop) or a family history of sudden infant death syndrome.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Variargil:

• If you are exposed to the sun, as photosensitivity reactions may occur. You should avoid prolonged sun exposure.
• If you are elderly, as side effects may occur more frequently.
• If you have severe vomiting.
• If you notice worsening 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 cardiovascular conditions, as alimemazine may cause hypotension and tachycardia.

Other medicines and Variargil

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

Taking Variargil with medicines for diarrhea or stomach acid may reduce the effects of Variargil.

If you are being treated with medicines to lower blood pressure, Variargil may increase their effect.

Do not combine with central nervous system depressant drugs (hypnotics, sedatives, anxiolytics) due to the risk of respiratory depression.

Taking Variargil with food and drinks

Do not drink alcoholic beverages during treatment.

Pregnancy, breastfeeding, and fertility

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

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

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

Driving and using machines

Variargil may cause drowsiness, especially at the start 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 told you that you have an intolerance to certain sugars, consult with them before taking this medicine. It may cause cavities.

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

This medicine may cause stomach upset and diarrhea because it contains macrogolglycerol hydroxystearate.

3. How to take Variargil

Follow exactly the administration instructions for this medicine contained in this leaflet or 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. Each drop is equivalent to

1.25 mg of alimemazine

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

-

• Adults and children over 12 years: 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: 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 at bedtime.

If you think the effect of Variargil is too strong or too weak, inform your doctor or pharmacist.

If you take more Variargil than you should

Consult your doctor or pharmacist immediately.

Symptoms of overdose may include: drowsiness, fainting, excitement, euphoria, hallucinations, or convulsions, and may even lead to sudden death.

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

If you forget to take Variargil

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The most common side effects, although mild, are sedation, drowsiness, and dry mouth, especially at the start of treatment.

Rarely, general side effects such as skin redness, itching, sensitivity to light, excessive sweating, and chills may occur.

Other side effects that may occur include blood disorders, cardiovascular (palpitations, tachycardia, hypotension), neurological (dizziness, confusion, concentration or movement coordination problems, especially in elderly patients; insomnia, nervousness, or irritability, especially in children), ocular (vision accommodation problems, pupil dilation), liver function (yellowing of skin and mucous membranes, usually transient), or kidney function (urinary retention, especially at high doses and in elderly patients).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Variargil

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Variargil composition

• The active ingredient is alimemazine as tartrate in an amount of 40 mg per ml. One drop is equivalent to 1.25 mg of alimemazine base.

• The other ingredients are saccharose, peppermint flavor, propylene glycol, citric acid, glycerol (E-422), sodium saccharin, and macrogolglycerol hydroxystearate and purified water.

Product appearance and packaging contents

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Farmacéuticos Logogen S.A.

San Rafael 3, 28108-Alcobendas (Madrid)

The manufacturer

ITALFARMACO S.A.

San Rafael 3, 28108-Alcobendas (Madrid)

Date of the last revision of this leaflet: July 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.