Heviran comfort
Poland
Table of Contents
Package leaflet: Information for the patient
Heviran Comfort, 50 mg/g, cream
Aciclovirum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician, pharmacist, or nurse.
- Keep this leaflet, so that you may read it again if necessary.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 10 days of treatment, or if symptoms worsen, contact your doctor.
Table of contents
- What Heviran Comfort is and what it is used for
- Important information before using Heviran Comfort
- How to use Heviran Comfort
- Possible side effects
- How to store Heviran Comfort
- Contents of the pack and other information
1. What Heviran Comfort is and what it is used for
Heviran Comfort cream for topical application contains the active substance aciclovir, an antiviral agent with strong activity against the herpes simplex virus (Herpes simplex).
Heviran Comfort cream is indicated for the local treatment of recurrent herpes labialis (cold sores) and facial herpes, caused by the herpes simplex virus Herpes simplex.
If there is no improvement after 10 days of treatment, or if symptoms worsen, contact your doctor.
2. Important information before using Heviran Comfort
When not to use Heviran Comfort
- if the patient is allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Heviran Comfort, consult a doctor, pharmacist, or nurse if:
- the patient is unsure whether the skin lesions are caused by herpes simplex.
Do not use Heviran Comfort without first consulting a doctor if:
- the patient's immune system is not functioning properly (e.g. following bone marrow transplantation or in patients with AIDS); immunocompromised individuals should consult a physician regarding treatment of any infection;
- the patient has particularly severe recurrent cold sores.
Do not apply the cream:
- to skin infections other than herpes;
- for the treatment of genital herpes;
- to mucous membranes (e.g. eyes, inside the mouth or nose).
Heviran Comfort should be used only for herpes lesions located on the lips and face.
Consult a doctor if, after 10 days of treatment, the herpes lesions have not disappeared, have not completely healed, or have worsened.
Avoid contact with the eyes. If the medicine gets into the eyes, rinse them thoroughly with warm water. In case of doubt, consult a doctor.
Wash hands before and after applying the cream to prevent spreading the infection to other areas of the skin. During treatment, avoid scratching blisters or scabs and do not touch them with a towel.
To reduce the risk of spreading the infection to other people, do not allow others to touch the affected skin areas or to use the same towels, etc.
Children
Do not use this medicine in children under 6 years of age.
Heviran Comfort and other medicines
Inform your doctor or pharmacist about any medicines the patient is currently using, has recently used, or plans to use.
Interactions between Heviran Comfort and other medicines are not known.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine.
Driving and using machines
Heviran Comfort has no effect or has a negligible effect on the ability to drive and operate machinery.
Heviran Comfort contains propylene glycol (E 1520), cetostearyl alcohol, and sodium lauryl sulfate
Each gram of cream contains 400 mg of propylene glycol. Propylene glycol may cause skin irritation.
The medicine contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
The medicine contains 7.5 mg of sodium lauryl sulfate in each gram of cream.
Sodium lauryl sulfate may cause local skin irritation (such as stinging or burning) or worsen skin reactions caused by other medicines applied to the same area of skin.
3. How to use Heviran Comfort
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Adults, adolescents and children over 6 years of age
Apply the medicine 5 times daily to the affected skin areas at approximately four-hour intervals, with a break at night. The medicine works most effectively when treatment is started as early as possible after the first symptoms of herpes appear, such as burning, itching or redness. Treatment may also be started later in the course of the disease, when blisters or sores appear.
Use in children aged 6 to 12 years
Use in children aged 6 to 12 years should be under medical supervision.
Duration of treatment
Treatment should continue for at least 4 days.
If skin lesions have not healed, treatment may be extended up to 10 days. If lesions have not resolved after 10 days of treatment, consult your doctor.
Method of administration
For topical use only.
Apply the medicine directly to the herpes lesions on the lips and face, avoiding touching them with your hands. Scratching the lesions or touching them with a towel should be avoided.
This medicine must be used by only one person. After the medicine packaging has been opened, it may be used only by one patient.
To prevent worsening or spreading of infection, hands should be washed before and after applying the medicine, and unnecessary rubbing of the affected areas or contact with towels should be avoided.
If you feel that the effect of Heviran Comfort is too strong or too weak, consult your doctor.
Accidental overdose of Heviran Comfort
If the cream is accidentally swallowed, contact your doctor or pharmacist immediately.
Missed dose of Heviran Comfort
Do not use a double amount to make up for a missed dose. If a dose is missed, apply the cream as soon as you remember, then continue treatment as before.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You must stop using this medicine and contact your doctor immediately if any of the following occur:
- an allergic reaction with symptoms including swelling of the face, lips and tongue, and difficulty breathing.
The following adverse reactions may occur:
Not common (occur in no more than 1 in 100 patients)
- mild drying or peeling of the skin
- transient burning, stinging or tingling sensation which may occur immediately after application of the cream
- itching.
Rare (occur in no more than 1 in 1,000 patients)
- redness
- contact dermatitis following application of aciclovir cream.
Very rare (occur in less than 1 in 10,000 patients)
- sudden hypersensitivity reactions, including severe reactions such as angioedema (a serious allergic reaction—swelling may affect the hands and feet, face, lips, tongue, throat and cause difficulty breathing) and urticaria (symptoms include itchy blisters and skin rash).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.
5. How to store Heviran Comfort
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
The shelf life after first opening the tube is 1 year.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.
6. Contents of the pack and other information
What Heviran Comfort contains
- The active substance is aciclovir. Each gram of cream contains 50 mg of aciclovir.
- The other ingredients are: cetostearyl alcohol, liquid paraffin, propylene glycol (E 1520), sodium lauryl sulfate, poloxamer 407, white vaseline, purified water.
What Heviran Comfort looks like and contents of the pack
Heviran Comfort is a white, smooth cream with a characteristic odour.
Heviran Comfort cream is packed in aluminium tubes with an epoxy-phenolic lacquer coating on the inside, fitted with a HDPE cap with a plug, and placed in a cardboard box.
Pack sizes: 2 g, 5 g or 10 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares, Rua Outeiro da Armada, 5
Condeixa-a-Nova 3150-194 Sebal, Portugal