Apofri

Cutaneous pin 50 mg / g 
(White to pale yellow, round pin with vanilla flavor.)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get side effects are, speak with your doctor or pharmacist This includes any possible adverse effects not listed in this leaflet. See section 4.
  • You must talk to your doctor if your symptoms worsen or do not improve 5 days after stopping treatment.

This leaflet contains information about: 
1. What Aciclovir Apofri is and what it is used for 
2. What you need to know before you use Aciclovir Apofri 
3. How to use Aciclovir Apofri 
4. Possible side effects 
5. How to store Aciclovir Apofri 
6. Contents of the pack and other information 

What Aciclovir Apofri is and what it is used for

The active substance in this medicine is aciclovir, which belongs to the group of antivirals. Aciclovir Apofri is used for treating cold sores on the lips and face caused by the herpes simplex virus in adults and adolescents over 12 years of age. The virus causes blisters or sores, especially on the lips, but also in other parts of the face. The viral infection can break out when the body’s immune system is weakened, for example in the case of cold or other infection. Strong sun, stress, or menstruation can also cause the symptoms. Aciclovir inhibits the virus’ ability to multiply, which causes the infection to stop and return.

Aciclovir contained in Aciclovir Apofri may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Aciclovir Apofri

Do not use Aciclovir Apofri

  • if you are allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before taking Aciclovir Apofri.

  • If you have a very high susceptibility to infection, for example, because you have AIDS or have had a bone marrow transplant, you should only use Aciclovir Apofri on the advice of a doctor.

Aciclovir Apofri is only for use on the skin of the lips or face. Do not use cream against other skin infections such as genital herpes. Avoid getting the pen in your mouth, eyes, and other mucous membranes, as it may cause irritation.

Children and young people

Aciclovir Apofri should not be used in children under 12 years of age.

Other medicines and Aciklovir Apofri

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Talk to your doctor before using Aciclovir Apofri if you are pregnant.

Breast-feeding

With local use of Aciclovir Apofri very little aciclovir is absorbed into the body. Aciclovir Apofri is unlikely to affect breastfed infants. Still consult a physician for more than temporary use.

Driving and using machines

No known effect on the ability to drive or use machines.

Aciclovir Apofri contains butylhydroxytoluene

Butylhydroxytoluene may cause local skin reactions (eg contact dermatitis) or be irritating to eyes and mucous membranes.

How to use Aciklovir Apofri

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Treatment should be started as soon as the first signs of cold sores appear. Infection usually manifests itself by itching, stinging, or itching. You can start treatment even if blisters have formed.

Adults and adolescents over 12 years:

Before applying the pin, you can warm it, for example in your hand or pocket. This makes the pin softer and easier to apply. The pin is applied to the cold sore 5 times a day approximately every four hours during the waking part of the day. To obtain a sufficient amount of the active ingredient aciclovir, the pen should be ironed 5 times over the entire mouth ulcer at each time, including the edges.

Treatment should be continued for at least five days. If you do not see that Aciklovir Apofri takes effect within 5 days, treatment can be continued for up to 7 days. Contact a doctor if the symptoms worsen or if the cold sore remains 5 days after the end of treatment.

Do not apply the pin immediately before a meal, as it may easily leak off.

To avoid spreading to other parts of the body or to the eyes, you should avoid touching the wound unnecessarily or letting others do it. The pin should only be used by one and the same person, and not shared with others. The pin can be used in the next cold sore outbreak, as long as it occurs before the expiration date.

Serious problems are not likely to occur if you have used a large number of pins in several places on the skin, or if you have swallowed a small number of pins after application.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Aciclovir Apofri and contact a doctor immediately if you get any of the following symptoms: swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing ( angioedema ). This is a very rare side effect (may affect up to 1 in 10,000 people).

Other side effects:

Uncommon (may affect up to 1 in 100 people): A burning, stinging sensation at the application site, mild dehydration, or flaking of the skin. Itching.

Rare (may affect up to 1 in 1,000 people):  Reddening of the skin ( erythema ). Contact dermatitis ( contact dermatitis ) at the application site. 

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Aciclovir Apofri

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

No special temperature instructions. Store in the original package. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is aciclovir. One gram of cutaneous pin contains 50 mg of aciclovir.
  • The other ingredients are castor oil, hard fat, carnauba wax, white petrolatum, white wax, octyldodecanol, butylhydroxytoluene, vanilla aroma.

What the medicine looks like and contents of the pack

Aciclovir Apofri is a white to pale yellow, round pin.

Packing with pin container with lid and screw device. The container contains 3 g of a cutaneous pin.

Pack sizes: 3 g.

Marketing Authorization Holder and Manufacturer

Apofri AB 
Box 120 
182 12 Danderyd

Manufacturer

Laboratorio Chimico Farmaceutico A. Sella srl 
Via Vicenza 67 
36015 Schio (Vicenza) 
Italy

Muhammad Nadeem

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