Hevipoint

Package Leaflet: Information for the Patient

Hevipoint, 200 mg, Tablets

Aciclovir

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

This Medication Should Always be Taken Exactly as Described in the Package Leaflet or as Advised by a Doctor or Pharmacist.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Need Advice or Further Information, Consult a Pharmacist.
• If You Experience any Side Effects, Including those not Listed in the Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
• If There is no Improvement or You Feel Worse After 5 Days, Consult a Doctor.

Package Leaflet Contents

• 1. What is Hevipoint and What is it Used for
• 2. Important Information Before Taking Hevipoint
• 3. How to Take Hevipoint
• 4. Possible Side Effects
• 5. How to Store Hevipoint
• 6. Package Contents and Other Information

1. What is Hevipoint and What is it Used for

Hevipoint, 200 mg, Tablets Contain the Active Substance Aciclovir - a Synthetic Antiviral Medication that Inhibits the Replication of Herpes Viruses. Hevipoint, 200 mg, Tablets are Indicated for the Treatment of Recurrent Herpes Labialis (Cold Sores) Caused by Herpes Simplex Virus in Adults. Hevipoint, 200 mg, Tablets Should Only be Used in Patients who have been Previously Diagnosed with Herpes Simplex Infection. If There is no Improvement or You Feel Worse After 5 Days, Consult a Doctor.

2. Important Information Before Taking Hevipoint

When Not to Take Hevipoint:

• If You are Allergic to Aciclovir or any of the Other Ingredients of this Medication (Listed in Section 6).

Warnings and Precautions

Before Taking Hevipoint, Discuss it with Your Doctor or Pharmacist. Do not Take Hevipoint Without Consulting a Doctor:

• If You have Kidney Problems,
• If You are Taking Other Medications that may Damage Your Kidneys,
• If You have a Weakened Immune System (e.g., After a Bone Marrow Transplant, HIV Infection). Patients with Weakened Immune Systems Should Consult a Doctor About Treatment for any Infection,
• If You are 65 Years or Older,
• In Case of Pregnancy or Breastfeeding,
• If You Experience Severe Recurrent Herpes Labialis,
• In Case of Frequent (> 6 per Year) and Prolonged (no Positive Treatment Effects After 5 Days) Recurrences of Herpes Labialis, with More Severe Clinical Symptoms (e.g., When New Lesions Appear After 3-4 Days of Treatment). This may Indicate an Immune Deficiency or Malabsorption Requiring Diagnosis and Different Dosage of the Medication.

If You are Uncertain Whether the Above Conditions Apply to You, Consult a Doctor Before Taking Hevipoint. Hydration StatusIf You are Taking Aciclovir, You Should Drink Plenty of Fluids to Maintain Proper Hydration.

Children and Adolescents

Hevipoint Should not be Used in Children and Adolescents Under 18 Years of Age.

Hevipoint and Other Medications

Tell Your Doctor or Pharmacist About all Medications You are Currently Taking or Plan to Take. Inform Your Doctor or Pharmacist Especially if You are Taking any of the Following Medications:

• Probenecid (Used to Treat Gout);
• Cimetidine (Used to Treat Stomach Ulcers);
• Tacrolimus, Cyclosporin, or Mycophenolate Mofetil (Used in Patients who have Undergone Organ Transplantation);
• Theophylline (Used to Treat Asthma and Other Respiratory Diseases).

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You may be Pregnant, or are Planning to have a Child, Consult a Doctor or Pharmacist Before Taking this Medication. You Should Avoid Taking the Medication During Pregnancy, Unless Your Doctor Decides that the Benefits of the Medication Outweigh the Potential Risks to the Fetus. You Should be Cautious When Taking the Medication While Breastfeeding, as Aciclovir Passes into Breast Milk. During Breastfeeding, the Medication Should Only be Used After Consulting a Doctor.

Driving and Operating Machinery

The Effect of Aciclovir on the Ability to Drive and Operate Machinery has not been Investigated. However, You Should Consider the Possibility of Side Effects such as Dizziness, Disorientation, Seizures.

Hevipoint Contains Sodium

The Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, Which Means it is Considered "Sodium-Free".

3. How to Take Hevipoint

This Medication Should Always be Taken Exactly as Described in the Package Leaflet or as Advised by a Doctor or Pharmacist. If You are Uncertain, Consult a Doctor or Pharmacist.

Adults

Hevipoint Should be Taken Orally in a Dose of 200 mg Five Times a Day, Every 4 Hours (with a Nightly Interval), for 5 Days. In Case of Recurrent Infections, it is Especially Important to Start Treatment During the Prodromal Phase (e.g., Tingling, Burning, Itching, or Tension) or Immediately After the Appearance of the First Lesions.

Dosage in Elderly Patients

In Elderly Patients, the Possibility of Renal Impairment Should be Considered. In Patients with Severe Renal Impairment (Creatinine Clearance Less than 10 ml/min), the Dosage of Aciclovir Should be Determined by a Doctor, Who Will Adjust the Dosage Accordingly (See: Dosage in Patients with Renal Impairment). During Treatment, You Should Drink Plenty of Fluids.

Use in Patients with Renal Impairment

Cautious Use of Hevipoint is Recommended in Patients with Renal Impairment. During Treatment with Hevipoint, Patients with Renal Impairment Should Drink Plenty of Fluids (See also Section 2 "Warnings and Precautions"). In Patients with Severe Renal Impairment (Creatinine Clearance Less than 10 ml/min), the Dosage of Aciclovir Should be Determined by a Doctor. In Such Patients, the Doctor May Recommend Reducing the Dosage to 1 Tablet (200 mg) Taken Twice a Day, Every 12 Hours.

Overdose of Hevipoint

Aciclovir is Generally Well-Tolerated, Unless Taken in Very High Doses for Several Days. Single Doses of Aciclovir up to 20 g are Usually Not Associated with Symptoms of Overdose. Unintentional, Repeated Overdose of Aciclovir for Several Days has been Associated with Gastrointestinal Symptoms (Nausea, Vomiting) and Neurological Symptoms (Headache, Confusion). If You Take Too Much of the Medication, Tell Your Doctor or Pharmacist or Contact the Nearest Hospital Emergency Department for Further Advice.

Missed Dose of Hevipoint

If You Miss a Dose, Take it as Soon as You Remember, Unless it is Time for the Next Dose. Do not Take a Double Dose to Make up for the Missed Dose. If You are Still Uncertain About the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Hevipoint can Cause Side Effects, Although not Everybody Gets Them.

Common Side Effects (May Affect up to 1 in 10 People):

• Headache, Dizziness,
• Nausea, Vomiting, Diarrhea, Abdominal Pain,
• Itching, Rash (Including Photosensitivity),
• Fatigue, Fever (High Body Temperature).

Uncommon Side Effects (May Affect up to 1 in 100 People):

• Hives,
• Accelerated, Widespread Hair Loss (May be Associated with Many Diseases and Medications, and its Relationship to Aciclovir is Uncertain).

Rare Side Effects (May Affect up to 1 in 1,000 People):

• Severe, Life-Threatening Allergic Reaction (Anaphylaxis),
• Angioedema (Most Commonly Affects the Face, Mainly the Lips and Eyelids, but can also Affect the Tongue, Glottis, or Larynx, and can be Life-Threatening),
• Dyspnea,
• Transient Increase in Bilirubin and Liver Enzyme Activity in the Blood,
• Increased Urea and Creatinine Levels in the Blood.

Very Rare Side Effects (May Affect up to 1 in 10,000 People):

• Decreased Red Blood Cell Count (Anemia), White Blood Cell Count (Leukopenia), and Platelet Count (Thrombocytopenia),
• Agitation, Disorientation, Tremors, Ataxia, Speech Disorders, Hallucinations, Psychotic Symptoms, Seizures, Somnolence, Brain Damage (Encephalopathy), Coma; these Events are Usually Transient and Typically Occur in Patients with Impaired Renal Function or Other Predisposing Factors (See Section 2),
• Hepatitis, Jaundice,
• Acute Renal Failure, Renal Pain.

Reporting Side Effects

If You Experience any Side Effects, Including those not Listed in the Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: 22 49-21-301, Fax: 22 49-21-309, Website: https://smz.ezdrowie.gov.pl. Side Effects can also be Reported to the Marketing Authorization Holder. By Reporting Side Effects, You can Help Provide More Information on the Safety of the Medication.

5. How to Store Hevipoint

Store the Medication in a Place that is Inaccessible to Children. Do not Use this Medication After the Expiration Date Stated on the Packaging. The Expiration Date Refers to the Last Day of the Specified Month. There are no Special Storage Instructions for the Medication. Medications Should not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Hevipoint Contains

• The Active Substance of the Medication is Aciclovir. One Tablet Contains 200 mg of Aciclovir.
• The Other Ingredients of the Medication are: Microcrystalline Cellulose, Povidone K30, Sodium Carboxymethylcellulose (Type A), Magnesium Stearate.

What Hevipoint Looks Like and What the Package Contains

White or Almost White, Round, Biconvex, with the Engraving "ACL" on one Side. Hevipoint is Available in PVC/Aluminum Blister Packs in a Cardboard Box. The Package Contains 30 Tablets.

Marketing Authorization Holder

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów

Manufacturer

Adamed Pharma S.A. ul. Marszałka J. Piłsudskiego 5 95-200 Pabianice

Date of the Last Update of the Package Leaflet: