Abacavir + Lamivudine Sandoz

Patient Information Leaflet: Important Information

Abacavir + Lamivudine Sandoz, 600 mg + 300 mg, Film-Coated Tablets

Abacavir + Lamivudine

Read All of This Leaflet Carefully Before Taking This Medicine.

• Keep This Leaflet. You May Need to Read It Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medicine Has Been Prescribed for You. Do Not Pass It on to Others. It May Harm Them, Even if Their Symptoms Are the Same as Yours.
• If You Experience Any Side Effects, Tell Your Doctor or Pharmacist. See Section 4.

Important - Hypersensitivity Reactions

Abacavir + Lamivudine Sandoz Contains Abacavir(Which Is Also an Active Substance in Trizivir, Triumeq, and Ziagen). Some Patients Taking Abacavir May Develop a Hypersensitivity Reaction(Severe Allergic Reaction) Which Can Be Life-Threatening If Treatment With Abacavir Is Continued.

It Is Essential to Read the Section on Hypersensitivity Reactions in Section 4 Carefully.

A Warning CardIs Included in the Packaging of Abacavir + Lamivudine Sandoz to Remind You and Your Healthcare Provider of the Risk of Hypersensitivity to Abacavir.

Remove the Card From the Packaging and Carry It With You at All Times.

Table of Contents of the Leaflet

• 1. What Abacavir + Lamivudine Sandoz Is and What It Is Used For
• 2. Important Information Before Taking Abacavir + Lamivudine Sandoz
• 3. How to Take Abacavir + Lamivudine Sandoz
• 4. Possible Side Effects
• 5. How to Store Abacavir + Lamivudine Sandoz
• 6. Contents of the Pack and Other Information

1. What Abacavir + Lamivudine Sandoz Is and What It Is Used For

Abacavir + Lamivudine Sandoz Is Used to Treat HIV Infection in Adults, Adolescents, and Children Weighing at Least 25 kg.

Abacavir + Lamivudine Sandoz Contains Two Active Substances Used to Treat HIV Infection: Abacavir and Lamivudine. These Belong to a Group of Anti-Retroviral Medicines Called Nucleoside Reverse Transcriptase Inhibitors (NRTIs). Abacavir + Lamivudine Sandoz Will Not Completely Cure HIV Infection, but It Will Reduce the Amount of Virus in Your Body and Keep It at a Low Level. It Will Also Increase the Number of CD4 Cells in Your Blood. CD4 Cells Are a Type of White Blood Cell That Plays an Important Role in Helping Your Body Fight Infection. Not All Patients Respond to Treatment With Abacavir + Lamivudine Sandoz in the Same Way. Your Doctor Will Monitor the Effectiveness of Your Treatment.

2. Important Information Before Taking Abacavir + Lamivudine Sandoz

When Not to Take Abacavir + Lamivudine Sandoz

If You Are Allergic (Hypersensitive) to Abacavir (or Any Other Medicine Containing Abacavir, Such as Trizivir, Triumeq, or Ziagen), Lamivudine, or Any of the Other Ingredients of This Medicine (Listed in Section 6).

Read Carefully the Section on Hypersensitivity Reactions in Section 4 of This Leaflet.

If You Think Any of the Above Applies to You, Consult Your Doctorand Do Not Take Abacavir + Lamivudine Sandoz.

Warnings and Precautions

Some People Taking Abacavir With Lamivudine or Other Combination Medicines for HIV Infection May Have a Higher Risk of Serious Side Effects. You Should Be Aware of the Extra Risk If You: Have Moderate or Severe Liver Disease; Have Had Liver Disease in the Past, Including Viral Hepatitis B or C (Patients With Hepatitis B Should Not Stop Taking Abacavir + Lamivudine Sandoz Without Their Doctor's Advice, as This May Cause a Return of Hepatitis B Symptoms); Are Overweight (Particularly Women); Have Kidney Problems.

If Any of the Above Applies to You, Discuss This With Your Doctor Before Taking Abacavir + Lamivudine Sandoz.

Tell Your Doctorif You Are Taking Any Other Medicines, Including Those You Have Bought Yourself Without a Prescription, Before You Start Taking Abacavir + Lamivudine Sandoz. It Is Especially Important to Tell Your Doctor if You Are Taking Any of the Following Medicines: Emtricitabine (Used to Treat HIV Infection); Other Medicines Containing Lamivudine (Used to Treat HIV Infection or Hepatitis B); High Doses of the Antibiotic Trimethoprim/Sulfamethoxazole; Cladribine (Used to Treat Hairy Cell Leukaemia); Tell Your Doctorif You Are Taking Any of These Medicines.

Some Medicines May Interact With Abacavir + Lamivudine Sandoz

These Include: Phenytoin (Used to Treat Epilepsy); Tell Your Doctorif You Are Taking Phenytoin. Your Doctor May Need to Monitor You More Closely; Methadone (Used as a Substitute for Heroin); Abacavir Increases the Rate at Which Methadone Is Removed From the Body. If You Are Taking Methadone, Your Doctor Will Monitor You for Signs of Methadone Withdrawal. You May Need a Change in Your Methadone Dose; Tell Your Doctorif You Are Taking Methadone; Medicines (Usually in Liquid Form) Containing Sorbitol and Other Sugar Alcohols (Such as Xylitol, Mannitol, Lactitol, or Maltitol), If Taken Regularly; Tell Your Doctoror Pharmacistif You Are Taking Any of These Medicines; Riociguat (Used to Treat High Blood Pressure in the Blood Vessels That Transport Blood From the Heart to the Lungs). Your Doctor May Need to Reduce the Dose of Riociguat.

Pregnancy

Abacavir + Lamivudine Sandoz Should Not Be Used During Pregnancy.

Abacavir + Lamivudine Sandoz and Similar Medicines May Cause Side Effects in the Unborn Child. If You Have Taken Abacavir + Lamivudine Sandoz, Your Doctor May Require You to Have Regular Blood Tests and Other Checks to Monitor the Development of Your Child. In Children Whose Mothers Took NRTIs During Pregnancy, the Benefits of Protecting Against HIV Outweigh the Risks of Side Effects.

Breast-Feeding

It Is Not RecommendedThat HIV-Infected Women Breast-Feed Their Babies Because HIV Can Be Passed to the Baby Through Breast Milk. A Small Amount of the Active Substances in Abacavir + Lamivudine Sandoz Can Also Pass Into Breast Milk. If You Are Breast-Feeding or Thinking of Breast-Feeding, Consult Your Doctor.

Driving and Using Machines

Abacavir + Lamivudine Sandoz May Cause Side Effects That Affect Your Ability to Drive or Use Machines. Talk to Your DoctorAbout Whether You Can Drive or Use Machines While Taking Abacavir + Lamivudine Sandoz.

Abacavir + Lamivudine Sandoz Contains a Yellow Dye Called Sunset Yellow FCF (E110)

This May Cause Allergic Reactions.

3. How to Take Abacavir + Lamivudine Sandoz

Always Take This Medicine Exactly as Your Doctor Has Told You. If You Are Not Sure, Check With Your Doctor or Pharmacist.

The Recommended Dose of Abacavir + Lamivudine Sandoz for Adults, Adolescents, and Children Weighing 25 kg or More Is One Tablet Once a Day.

Swallow the Tablets Whole With Water. You Can Take Abacavir + Lamivudine Sandoz With or Without Food.

Stay in Close Contact With Your Doctor

Abacavir + Lamivudine Sandoz Helps to Control Your Condition. To Get the Best Effect, You Must Take It Every Day. You May Still Develop Other Infections and Diseases Associated With HIV.

Do Not Stop Taking Abacavir + Lamivudine Sandoz Without Consulting Your Doctor

Do Not Stop Taking Abacavir + Lamivudine SandozWithout Your Doctor's Advice.

If You Take More Abacavir + Lamivudine Sandoz Than You Should

If You Accidentally Take Too Much Abacavir + Lamivudine Sandoz, Tell Your Doctor or Pharmacistor Go to the Nearest Hospital Casualty Department. Take the Medicine Pack With You.

If You Forget to Take Abacavir + Lamivudine Sandoz

If You Forget to Take a Dose, Take It as Soon as You Remember. Then Continue to Take Your Next Dose at the Usual Time. Do Not Take a Double Dose to Make Up for a Forgotten Dose. It Is Important to Take Abacavir + Lamivudine Sandoz Regularly, as Irregular Use Increases the Risk of Hypersensitivity Reactions.

If You Stop Taking Abacavir + Lamivudine Sandoz

If You Stop Taking Abacavir + Lamivudine Sandoz for Any Reason, Especially if You Think You Might Have Had a Side Effect or If You Have Another Illness: Tell Your Doctor Before You Start Taking Abacavir + Lamivudine Sandoz Again. Your Doctor Will Check Whether the Symptoms You Had Were Due to a Hypersensitivity Reaction. If Your Doctor thinks they might be, They Will Advise You to Never Take Abacavir + Lamivudine Sandoz or Any Other Medicine Containing Abacavir (Such as Trizivir, Triumeq, or Ziagen) Again. It Is Very Important to Follow This Advice.

4. Possible Side Effects

During HIV Treatment, Weight Gain and Increases in Blood Lipids and Glucose May Occur. This Is Partly Due to the Recovery of the Body and Partly Due to the Side Effects of HIV Medicines. Your Doctor Will Monitor These Changes.

Like All Medicines, Abacavir + Lamivudine Sandoz Can Cause Side Effects, Although Not Everybody Gets Them. During HIV Treatment, It May Not Always Be Possible to Identify Whether a Side Effect Is Due to Abacavir + Lamivudine Sandoz or Other Medicines You Are Taking, or the HIV Disease Itself. It Is Very Important to Report All Changes in Your Health to Your Doctor.

Hypersensitivity Reaction

A Hypersensitivity Reaction (Severe Allergic Reaction)Can Happen in Some Patients Taking Abacavir (See Section 2). This Can Be a Serious and Possibly Life-Threatening Side Effect. Read Carefully the Section on Hypersensitivity Reactions in This Leaflet.

Other Possible Side Effects of Combination Therapy for HIV

Treatment With Abacavir + Lamivudine Sandoz and Other Anti-HIV Medicines May Also Cause Other Conditions to Develop. These Include:

Infections and Inflammatory Conditions

Old Infections May Come Back

When You Are Being Treated for HIV, It Is Not Uncommon for Old, Hidden Infections to Come Back. The Signs of an Old Infection Come Back Because Your Body Is Starting to Recover. If This Happens to You, Tell Your Doctor Straight Away.

Autoimmune Disorders (a Condition Where the Body's Immune System Attacks Healthy Tissue)

Autoimmune Disorders, Such as Aids-Related Myopathy, Guillain-Barré Syndrome, or Polymyositis, May Also Occur After You Start Taking Medicines to Treat Your HIV Infection.

Bone Problems

Some Patients Taking Combination Therapy for HIV Develop a Condition Called Osteonecrosis (Death of Bone Tissue Caused by a Lack of Blood Supply). The Risk of Osteonecrosis Is Greater in Patients With Advanced HIV Disease or Who Have Been Taking Combination Therapy for a Long Time. If You Experience Pains in Your Joints, Especially in Your Hip, Knee, or Ankle, Tell Your Doctor.

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 (See Details Below). By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Abacavir + Lamivudine Sandoz

Keep This Medicine Out of the Sight and Reach of Children.

Do Not Use This Medicine After the Expiry Date Which Is Stated on the Carton and Blister After EXP. The Expiry Date Refers to the Last Day of That Month.

Store in a Cool, Dry Place. Below 25°C.

Do Not Throw Away Any Medicines Via Wastewater or Household Waste. Ask Your Pharmacist How to Throw Away Medicines You No Longer Use. These Measures Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Abacavir + Lamivudine Sandoz Contains

• The Active Substances Are Abacavir and Lamivudine. Each Film-Coated Tablet Contains 600 mg of Abacavir (as Hydrochloride) and 300 mg of Lamivudine.
• The Other Ingredients Are: Microcrystalline Cellulose (Ceolus KG 802), Microcrystalline Cellulose (PH 102), Crospovidone (Type A), Povidone K-30, Yellow Iron Oxide (E172), Magnesium Stearate; Coating: Hypromellose 3mPas, Hypromellose 6mPas, Titanium Dioxide (E171), Macrogol 400, Polysorbate 80, and Sunset Yellow FCF (E110), Lake (15-18%), Sunset Yellow FCF (E110), Lake (38-42%).

What Abacavir + Lamivudine Sandoz Looks Like and Contents of the Pack

Abacavir + Lamivudine Sandoz Film-Coated Tablets Are Orange, Convex, Capsule-Shaped, 20.6 mm x 9.1 mm, With "300" Engraved on One Side and "600" on the Other Side. The Tablets Are Packaged in Blisters (PVC/Aclar/PVDC/Aluminium or PVC/PVDC/Aluminium) Containing 30, 60, or 90 Film-Coated Tablets, in a Carton, or in HDPE Bottles (With a Desiccant Sachet), Containing 30 Film-Coated Tablets, in a Carton. Not All Pack Sizes May Be Available.

Marketing Authorisation Holder

Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria

Manufacturer

Hormosan Pharma GmbH, Wilhelmshöher Str. 106, D-60389 Frankfurt/Main, Germany; Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany; Lek Pharmaceuticals, d.d., Verovskova Ulica 57, Ljubljana, 1526, Slovenia

For More Information on This Medicine, Including Its Name in the Member States of the European Economic Area

Contact Sandoz Polska Sp. z o.o., ul. Domaniewska 50 C, 02-672 Warszawa, tel. 22 209 70 00

Date of Last Revision of the Leaflet:12/2024

Sandoz Logo