Variargil 40 mg/ml oral solution drops
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Variargil 40 mg/ml oral drops solution
Alimemazine
Read the entire leaflet carefully before you start taking this medicine, because 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 other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Variargil is and what it is used for
- What you need to know before taking Variargil
- How to take Variargil
- Possible side effects
- How to store Variargil
- Contents of the pack and other 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 substance, to phenothiazines (e.g. chlorpromazine), or to 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 benign prostatic hyperplasia (enlarged prostate), closed-angle glaucoma, Parkinson's disease, epilepsy, hypothyroidism, pheochromocytoma, or myasthenia gravis (a muscle disorder)
- Children over 2 years of age with severe dehydration or acute illnesses
Children over 2 years of age with a history of nocturnal apnea (cessation of breathing during sleep) 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 sunlight, as photosensitivity reactions may occur. You should avoid prolonged exposure to sunlight.
- If you are elderly, as adverse 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 that you consult your doctor, as it may be necessary to discontinue treatment.
- If you have any cardiovascular condition, since alimemazine may cause hypotension and tachycardia.
Other medicines and Variargil
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Concomitant use with medications for diarrhea or stomach acidity may reduce the effects of Variargil.
If you are being treated with medications to lower blood pressure, Variargil may enhance their effect.
Do not combine with central nervous system (CNS) depressants (e.g. hypnotics, sedatives, anxiolytics) due to the risk of respiratory depression.
Taking Variargil with food and drinks
Do not consume alcoholic beverages during treatment.
Pregnancy, breastfeeding, and fertility
Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
As a general rule, use during the first trimester of pregnancy and during the two weeks before delivery is not recommended.
Alimemazine is excreted in breast milk; therefore, breastfeeding women should consult their doctor before using this medicine.
Driving and using machines
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 dangerous machinery, including automobiles, until they know how they tolerate the medicine.
Variargil contains sucrose and macrogolglycerol hydroxystearate
This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine. It may cause dental caries.
This medicine contains less than 23 mg of sodium (1 mmol) per drop; thus, it is essentially "sodium-free".
This medicine may cause stomach discomfort and diarrhea because it contains macrogolglycerol hydroxystearate.
3. How to take Variargil
Follow exactly the administration instructions for this medicine as stated in this leaflet or as directed by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse.
For accurate dosing, the bottle is equipped with a dropper cap. Each drop corresponds to
1.25 mg of alimemazine.
This medicine is administered orally. The recommended dose is as follows:
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Adults and children over 12 years: 8 drops (10 mg) two or three times daily; maximum daily dose 24 drops (30 mg of alimemazine)
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Use in elderly patients: 8 drops (10 mg) once or twice daily; maximum daily dose 16 drops (20 mg of alimemazine)
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Use in children over 2 years: 2–4 drops (2.5–5 mg) two or three times daily, meaning a maximum daily dose of 12 drops (15 mg of alimemazine)
It is recommended to take the higher dose at bedtime.
If you feel that 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 seizures, potentially leading to sudden death.
In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone number 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 missed doses.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them. The most common adverse effects, although generally mild, are sedation, somnolence, and dryness of mucous membranes, especially at the beginning of treatment.
Rarely, general adverse effects may occur, such as skin redness, itching, light sensitivity, excessive sweating, chills.
Other possible adverse effects include blood disorders, cardiovascular effects (palpitations, tachycardia, hypotension), neurological effects (dizziness, confusion, difficulty concentrating or impaired coordination of movements, especially in elderly patients; insomnia, nervousness or irritability, especially in children), ocular effects (vision accommodation problems, pupil dilation), liver function disturbances (yellowing of the skin and mucous membranes, usually transient), and kidney function effects (urinary retention, especially at high doses and in elderly patients).
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Variargil
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The active substance is alimemazine as tartrate salt in an amount of 40 mg per ml. One drop corresponds to 1.25 mg of alimemazine base.
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The other components are sucrose, peppermint flavor, propylene glycol, citric acid, glycerol (E-422), sodium saccharin, macrogol glycerol hydroxystearate, and purified water q.s.
Appearance of the medicine and contents of the pack
It is presented in a 30 ml bottle with dropper cap.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Farmacéuticos Logogen S.A.
San Rafael 3, 28108-Alcobendas (Madrid)
Manufacturer
ITALFARMACO S.A.
San Rafael 3, 28108-Alcobendas (Madrid)
Date of the most recent review of this leaflet: July 2020
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.