Aciclovir Hikma

Package Leaflet: Information for the Patient

Aciclovir Hikma, 250 mg, Powder for Solution for Infusion

Aciclovir Hikma, 500 mg, Powder for Solution for Infusion

Aciclovir

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor or Nurse.
• If the Patient Experiences Any Side Effects, Including Those Not Mentioned in this Package Leaflet, Inform the Doctor or Nurse. See Section 4.

Package Leaflet Contents

• 1. What is Aciclovir Hikma and What is it Used For
• 2. Important Information Before Using Aciclovir Hikma
• 3. How to Use Aciclovir Hikma
• 4. Possible Side Effects
• 5. How to Store Aciclovir Hikma
• 6. Package Contents and Other Information

1. What is Aciclovir Hikma and What is it Used For

Aciclovir Hikma Contains the Active Substance Aciclovir. It Belongs to a Group of Medicines Called Antiviral Medicines. Its Mechanism of Action Involves Killing Viruses or Inhibiting Their Growth.

Aciclovir Hikma Can be Used to:

• Treat Infections Caused by the Varicella-Zoster Virus (Chickenpox) and Herpes Zoster (Shingles);
• Treat Severe Cases of Genital Herpes;
• Prevent and Treat Infections Caused by the Herpes Simplex Virus (Cold Sores and Genital Herpes) in People with Weakened Immune Systems, Meaning Their Body Fights Infections Less Well;
• Treat Herpes Simplex Virus Infections in Children Under 3 Months of Age. This Type of Infection is Rarely Caused by the Virus Responsible for Cold Sores and Genital Herpes;
• Treat Herpes Simplex Encephalitis (a Rare Infection Caused by the Virus Responsible for Cold Sores and Genital Herpes).

2. Important Information Before Using Aciclovir Hikma

When Not to Use Aciclovir Hikma:

• If the Patient is Allergic to Aciclovir or Valaciclovir, or Any of the Other Ingredients of this Medication (Listed in Section 6).

Warnings and Precautions

Before Starting Aciclovir Hikma, Discuss it with a Doctor or Nurse.

Consult a Doctor or Nurse Before Using Aciclovir Hikma if:

• The Patient Has Kidney Problems;
• The Patient is Over 65 Years Old. If it is Not Known if the Above Applies to the Patient, Consult a Doctor or Nurse Before Using Aciclovir Hikma.

Aciclovir Hikma and Other Medicines

Tell the Doctor About All Medicines the Patient is Currently Taking or Has Recently Taken, as Well as Any Medicines the Patient Plans to Take.

Inform the Doctor or Pharmacist if the Patient is Taking Any of the Following Medicines:

• Probenecid Used to Treat Gout;
• Cimetidine Used to Treat Stomach Ulcers;
• Tacrolimus, Cyclosporin, or Mycophenolate Mofetil Used to Prevent Transplanted Organs from Being Rejected by the Body;
• Lithium Used to Treat Manic-Depressive Disorders;
• Theophylline Used to Treat Certain Breathing Disorders.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks They May be Pregnant, or Plans to Have a Child, They Should Consult a Doctor Before Using this Medication.

Aciclovir Hikma Contains Sodium

Aciclovir Hikma Contains 37.8 mg of Sodium per Dose. This Information Should be Taken into Account by Patients on a Controlled Sodium Diet.

3. How to Use Aciclovir Hikma

The Patient Will Never Administer this Medication Themselves. It is Always Administered by a Trained Healthcare Professional.

Before Administration, the Medication Will be Diluted.

Aciclovir Hikma is Administered as a Continuous Intravenous Infusion. The Medication is Administered Slowly into a Vein Over 1 Hour.

Aciclovir Hikma is Usually Administered Every 8 Hours.

The Patient May Receive Fluids to Prevent Dehydration.

The Dose, Frequency of Administration, and Duration of Administration Will Depend on:

• The Type of Infection the Patient Has;
• The Patient's Body Weight;
• The Patient's Age.

The Doctor May Change the Dose of Aciclovir Hikma if:

• The Patient Has Kidney Problems. If the Patient Has Kidney Problems, it is Essential to Drink Plenty of Fluids While Taking Aciclovir Hikma;
• The Patient is Overweight or Obese;
• The Patient is Elderly. If the Above Applies to the Patient, Consult a Doctor Before Using Aciclovir Hikma.

Use in Children

The Dose of Aciclovir Hikma Administered to:

• Children Aged 3 Months to 12 Years is Calculated Based on Body Surface Area;
• Infants Under 3 Months is Calculated Based on Body Weight. If the Child Has Kidney Problems, the Dose May be Reduced.

Overdose of Aciclovir Hikma

If it is Suspected that the Patient Has Taken Too Much Aciclovir Hikma, Inform a Doctor or Nurse Immediately.

If the Patient Has Taken Too Much Aciclovir Hikma, They May:

• Feel Confused or Agitated;
• Have Hallucinations (See or Hear Things that Do Not Exist);
• Have Seizures;
• Lose Consciousness (Coma).

4. Possible Side Effects

Like All Medicines, Aciclovir Hikma Can Cause Side Effects, Although Not Everybody Gets Them.

The Following Side Effects May Occur When Using this Medication:

Allergic Reactions(in Less Than 1 in 10,000 People)

If the Patient Experiences an Allergic Reaction, Stop Using Aciclovir Hikma and Seek Medical Attention Immediately. Symptoms May Include:

• Rash, Itching, or Hives on the Skin;
• Swelling of the Face, Lips, Tongue, or Other Parts of the Body;
• Wheezing, Whistling, or Difficulty Breathing;
• Fever (High Body Temperature) of Unknown Cause and Feeling of Fainting, Especially When Standing.

Other Side Effects Include:

Common(in Less Than 1 in 10 People)

• Nausea or Vomiting;
• Itchy Rash Resembling Hives;
• Skin Reaction to Light (Photosensitivity);
• Itching;
• Swelling; Redness and Tenderness at the Injection Site.

Uncommon(in Less Than 1 in 100 People)

• Frequent Nosebleeds and Bruising.

Rare(in Less Than 1 in 10,000 People)

• Headache or Dizziness;
• Diarrhea or Abdominal Pain;
• Feeling Tired;
• Fever;
• Affecting Some Blood and Urine Test Results;
• Weakness;
• Agitation or Confusion;
• Shivering or Shaking;
• Hallucinations (Seeing or Hearing Things that Do Not Exist);
• Seizures;
• Feeling Abnormally Drowsy;
• Difficulty Walking and Lack of Coordination;
• Difficulty Speaking;
• Difficulty Thinking Logically or Assessing a Situation;
• Losing Consciousness (Coma);
• Paralysis of Part or All of the Body;
• Behavioral, Speech, or Eye Movement Disorders;
• Stiff Neck and Sensitivity to Light;
• Hepatitis;
• Yellowing of the Skin and Whites of the Eyes (Jaundice);
• Kidney Problems Related to Passing Small Amounts of Urine or Complete Inability to Pass Urine;
• Pain in the Lower Back, Kidney Area, or Above the Hip (Kidney Pain).

Reporting Side Effects

If Any Side Effects Occur, Including Those Not Mentioned in this Package Leaflet, Inform a Doctor or Nurse.

Side Effects Can be Reported Directly to:

Department of Medicinal Product Monitoring, 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

Email: [[email protected]](mailto:[email protected])

Side Effects Can Also be Reported to the Marketing Authorization Holder.

Reporting Side Effects Will Help to Gather More Information on the Safety of this Medication.

5. How to Store Aciclovir Hikma

Store the Medication Out of Sight and Reach of Children.

Store in a Temperature Below 25°C.

Prepare the Medication Immediately Before Use. Discard Any Unused Medication.

Do Not Use this Medication After the Expiration Date Stated on the Label and Carton: Expiration Date (EXP). The Expiration Date Refers to the Last Day of the Month Stated.

6. Package Contents and Other Information

What Aciclovir Hikma Contains

• The Active Substance is Aciclovir. Each Vial Contains 250 mg of Aciclovir as Sodium Salt. Each Vial Contains 500 mg of Aciclovir as Sodium Salt.
• The Other Ingredient is Sodium Hydroxide.

What Aciclovir Hikma Looks Like and What the Package Contains

Aciclovir Hikma is Available in Vials Made of Type I Glass Containing a White Powder, with a Bromobutyl Rubber Stopper and an Aluminum Cap.

The 250 mg Strength is Available in 10 ml Vials, in a Carton Containing 5 or 10 Vials.

The 500 mg Strength is Available in 20 ml Vials, in a Carton Containing 5 or 10 Vials.

Not All Pack Sizes May be Marketed.

Marketing Authorization Holder and Manufacturer

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, 8, 8A e 8B – Fervença

2705-906 Terrugem SNT

Portugal

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Italy:

Aciclovir Hikma 250 mg and 500 mg Powder for Solution for Infusion

Germany:

Aciclovir Hikma 250 mg and 500 mg Powder for Solution for Infusion

Portugal:

Aciclovir Hikma, 250 mg and 500 mg, Powder for Solution for Infusion

Date of Last Revision of the Package Leaflet: 03/2017.

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Information Intended for Healthcare Professionals Only:

Shelf-Life of the Reconstituted Solution

From a Chemical and Physical Point of View, the Solution Remains Stable for 12 Hours at a Temperature Between 15°C and 25°C.

From a Microbiological Point of View, the Medication Should be Used Immediately. If the Medication is Not Used Immediately, the Responsibility for the Storage Time After Reconstitution and the Storage Conditions Lies with the User.

Special Precautions for Disposal and Preparation of the Medicinal Product

Reconstitution:

A Solution of Aciclovir Hikma Containing 25 mg of Aciclovir per ml Should be Prepared by Adding the Following Volumes of Water for Injections or 0.9% Sodium Chloride Solution for Intravenous Injections (0.9%):

Medication Form

Volume of Reconstitution Solution

Vial Containing 250 mg

10 ml

Vial Containing 500 mg

20 ml

Based on the Calculated Dose, Determine the Appropriate Number and Size of Vials Needed for Use.

To Reconstitute the Contents of the Vials, Add the Recommended Volume of Solution for Infusion to Each Vial and Gently Shake the Vial Until the Contents are Completely Dissolved.

Method of Administration:

The Required Dose of Aciclovir Hikma Should be Administered as a Slow Intravenous Infusion Over at Least 1 Hour.

After Reconstitution, Aciclovir Hikma Can be Administered Using an Infusion Pump with a Controlled Infusion Rate.

Furthermore, it is Possible to Further Dilute the Reconstituted Solution to Administer Aciclovir in an Intravenous Infusion at a Concentration Not Exceeding 5 mg/ml (0.5% w/v).

Add the Required Volume of Reconstituted Solution to the Selected Infusion Solution According to the Following Recommendations and Shake Well to Ensure Complete Mixing of the Contents.

In the Case of Children and Infants, When the Smallest Volume of Infusion Solution is Indicated, it is Recommended to Dilute in Such a Way that 4 ml of Reconstituted Solution (100 mg of Aciclovir) is Added to 20 ml of Infusion Solution.

In the Case of Adults, it is Recommended to Use Infusion Bags Containing 100 ml of Infusion Solution, Even if this Results in an Aciclovir Concentration Significantly Below 5 mg/ml (0.5% w/v).

Therefore, One Infusion Bag of 100 ml Can be Used for Any Dose Between 250 mg and 500 mg of Aciclovir (10 ml to 20 ml of Reconstituted Solution), While for Doses of 500 mg to 1000 mg, a Second Bag Must be Used.

After Dilution According to the Recommended Scheme, Aciclovir Hikma Shows Pharmaceutical Compatibility with the Following Infusion Solutions and Remains Stable for Up to 12 Hours at Room Temperature (15°C-25°C):

• 0.9% Sodium Chloride Solution
• 0.45% Sodium Chloride Solution and 4% Glucose Solution
• 0.9% Sodium Chloride Solution and 2.5% Glucose Solution
• Multicomponent Solution of Sodium Lactate (Hartmann Solution) for Intravenous Infusion

Aciclovir Hikma, After Dilution According to the Above Scheme, Will Ensure an Aciclovir Concentration Not Exceeding 5 mg/ml (0.5% w/v).

Given the Absence of Antimicrobial Preservatives, Reconstitution and Dilution of the Medication Should be Carried Out Under Aseptic Conditions Immediately Before Use, and Any Unused Solution Should be Discarded.

Reconstituted or Diluted Solutions Should Not be Stored in the Refrigerator.

If Any Visible Precipitation or Crystals Appear in the Solution Before or During Infusion, the Solution Should Not be Used.