RETROVIR 250 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Retrovir 250 mg Hard Capsules

zidovudina

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience side effects, consult your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Retrovir and what is it used for
2. What you need to know before you take Retrovir
3. How to take Retrovir
4. Possible side effects
5. Storing Retrovir
6. Contents of the pack and further information

1. What is Retrovir and what is it used for

Retrovir is used to treat HIV (Human Immunodeficiency Virus) infection.

The active substance of Retrovir is zidovudina. Retrovir belongs to a group of medicines called antiretrovirals. It belongs to a group of medicines known as Nucleoside Reverse Transcriptase Inhibitors (NRTIs).

Retrovir does not eliminate HIV infection. It reduces the amount of virus in your body and keeps it at a low level. Retrovir also increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that is important for fighting infections.

Retrovir is used in combination with other medicines (combination therapy) to treat HIV in adults and children. To control HIV infection and prevent it from getting worse, you must take all your medicines.

If you are pregnant, your doctor may prescribe Retrovir to help prevent HIV from being passed to the baby. After birth, the baby may also need to take Retrovir to prevent HIV infection.

HIV infection is spread through sexual contact with an infected person or through contact with infected blood (for example, by sharing needles).

2. What you need to know before you take Retrovir

Do not take Retrovir

• (hypersensitive) to zidovudina or any of the other ingredients of Retrovir (listed in section 6)
• (neutropenia) or very low red blood cell counts(anemia)

Retrovir for newborns

Retrovir should not be given to newborns with liver problems, including:

• some cases ofhyperbilirubinemia(high levels of a substance called bilirubin in the blood that can cause yellowing of the skin)
• other problems that cause high levels of liver enzymes in the blood

Be careful with Retrovir

Some patients treated with Retrovir or with combination therapy for HIV have a higher risk of experiencing serious side effects. You should be aware of these possible risks if:

• you have ever had liver disease(including hepatitis B or C)
• you are significantly overweight(especially if you are a woman)

• Talk to your doctor if any of the above applies to you. You may need more frequent visits to your doctor, even more blood tests while taking the medicine. See section 4 for more information.

Important symptoms to look out for

In some patients with HIV infection, signs and symptoms may appear, sometimes severe, during treatment with Retrovir.

Read carefully the information in section 4 of this leaflet, if you have any questions about this information:

• Consult your doctor.

Other medicines and Retrovir

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal medicines or those bought without a prescription. Remember to inform your doctor or pharmacist if you start taking any new medicine during treatment with Retrovir.

Do not take these medicines with Retrovir:

• stavudine, to treat HIV infection
• ribavirinor injections ofganciclovir, to treat viral infections
• rifampicin, an antibiotic.

Some medicines may increase the risk of side effects or make them worse, for example:

• sodium valproate, used to treatepilepsy
• aciclovir, ganciclovir, or interferon, used to treatviral infections
• pyrimethamine, used to treatmalariaand other parasitic infections
• dapsone, used to preventpneumoniaand treatskin infections
• fluconazoleor flucytosine, used to treatfungal infectionssuch asCandida
• pentamidineor atovaquone, to treat parasitic infections such asPneumocystispneumonia (PCP)
• amphotericinor cotrimoxazole, used to treatfungal or bacterial infections
• probenecid, used to treatgoutand similar conditions, and given with some antibiotics to make them more effective
• methadone, used as aheroin substitute
• vincristine, vinblastine, or doxorubicin, used to treatcancer.

• Tell your doctorif you are taking any of these medicines.

Some of the medicines that interact with Retrovir are:

• clarithromycin, an antibiotic
• phenytoin, used to treatepilepsy.

• Tell your doctorif you are taking clarithromycin or phenytoin. Your doctor may need to monitor you while you are taking Retrovir.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby:

• Consult your doctorabout the benefits and risks of taking Retrovir.

If HIV-positive pregnant women take Retrovir, they are less likely to pass the HIV infection to their baby.

Retrovir and similar medicines can cause side effects in the fetus. If you have been taking Retrovir during your pregnancy, your doctor may ask for regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV was greater than the risk of side effects.

Breast-feeding

It is not recommendedthat HIV-positive women breast-feed because HIV infection can be passed to the baby through breast milk.

A small amount of the components of Retrovir may also pass into breast milk.

If you are breast-feeding or thinking of breast-feeding, consult your doctor as soon as possible.

Driving and using machines

Retrovir may affect your ability to drive and use machines, as it can cause dizzinessand other side effects that may make you less alert.

• Do not drive or operate toolsormachinesunless you feel well.

Retrovir contains sodium

This medicine contains less than 23 mg of sodium(1 mmol) per dose; this is, essentially “sodium-free”.

You will need regular blood tests

During treatment with Retrovir, your doctor will ask for regular blood tests to check for side effects. For more information on side effects, see section 4 of this leaflet.

Stay in regular contact with your doctor

Retrovir helps control your disease, but it does not cure HIV infection. You will need to take it every day to prevent the disease from getting worse. You may develop other infections associated with HIV infection.

• Stay in touch with your doctor and do not stop taking Retrovirwithout their advice.

3. How to take Retrovir

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Swallow the hard capsules whole with a little water.

How much Retrovir will you need to take?

Adults and adolescents weighing at least30 kg:

The normal dose of Retrovir is 250 mg twice a day. Take the doses 12 hours apart.

Children:

Children can take zidovudina in oral solution or 100 mg capsules.

Dosage during pregnancy and childbirth:

Retrovir is not recommended for administration to pregnant women with less than 14 weeks of pregnancy. After the fourteenth week, your doctor may prescribe 500 mg, administered as 100 mg five times a day, until the start of labor. During labor, your doctor may decide to use injectable zidovudina until the umbilical cord is cut. It is also possible that Retrovir will be given to the newborn to prevent HIV infection.

Dosage in patients with kidney or liver problems:

If you have severe kidney or liver problems, your doctor may decide to use a lower dose, depending on the function of these organs. Follow your doctor's advice.

If you take more Retrovir than you should

If you take more Retrovir than you should, consult your doctor or pharmacist. If possible, show them the Retrovir packaging.

If you forget to take Retrovir

If you forget to take a dose, do not worry. You can take the next dose as soon as you remember, but not within 2 hours before the next dose. If you remember when there are less than 2 hours left for the next dose, simply skip the missed dose and take the next one at the usual time. Then continue your treatment as before.

Do not take a double dose to make up for missed doses.

If you stop taking Retrovir

Do not stop taking Retrovir without medical advice

Take Retrovir for as long as your doctor has told you. Do not stop taking it unless your doctor tells you to.

4. Possible Adverse Effects

During HIV treatment, there may be an increase in weight and glucose and lipid levels in the blood. This may be partly related to the recovery of health and lifestyle, and in the case of blood lipids, sometimes to HIV medications themselves. Your doctor will monitor these changes.

Treatment with zidovudine (Retrovir) often causes fat loss from the legs, arms, and face (lipoatrophy). This fat loss has been shown to be not completely reversible after stopping zidovudine. Your doctor should monitor signs of lipoatrophy. If you notice any fat loss in your legs, arms, and face, inform your doctor. When these symptoms occur, you should stop taking Retrovir and change your HIV treatment.

Like all medications, this medication can produce adverse effects, although not all people suffer from them. Some adverse effects may be reflected in your blood tests, and may not appear until 4-6 weeks after starting to take Retrovir. If you suffer from any of these adverse effects, and if they are severe, your doctor may advise you to stop taking Retrovir.

In addition to the effects described below, others may appear during combined HIV treatment.

• It is important to read the information on “Other possible adverse effects of combined HIV treatment”.

Very Common Adverse Effects

May affect more than 1 in 10people treated with Retrovir:

• headache
• nausea.

Common Adverse Effects

May affect up to 1 in 10people treated with Retrovir:

• vomiting
• diarrhea
• stomach pain
• dizziness
• muscle pain
• general feeling of discomfort.

Common adverse effects that may appear in blood tests are:

• decrease in the number of red blood cells (anemia) and white blood cells (leukopeniaor neutropenia)
• increase in liver enzymes in the blood
• increase in bilirubin(a substance produced in the liver) in the blood, which can give a yellowish color to the skin.

Uncommon Adverse Effects

May affect up to 1 in 100people treated with Retrovir:

• skin rash (redness, swelling, or itching of the skin)
• difficulty breathing
• fever (high temperature)
• generalized pain and fatigue
• flatulence
• weakness.

Uncommon adverse effects that may appear in blood tests are:

• reduction in the number of blood cells involved in blood clotting (thrombocytopenia) or all types of blood cells (pancytopenia).

Rare Adverse Effects

May affect up to 1 in 1,000people treated with Retrovir:

• lactic acidosis (excess of lactic acid in the blood; see the following section, “Other possible adverse effects of combined HIV treatment”)
• liver disorders, such as jaundice, liver enlargement, and fatty liver
• pancreatitis
• chest pain, heart disorders
• seizures
• anxiety and depression, insomnia, lack of concentration, drowsiness
• indigestion, loss of appetite, alteration of taste
• changes in the coloration of the nails, skin, or mucous membranes
• flu-like syndrome: chills, sweating, and cough
• tingling sensation in the skin (like having pins and needles)
• frequent urination
• increase in breast size in men.

A rare adverse effect that may appear in blood tests is:

• decrease in the number of a type of red blood cell (pure red cell aplasia).

Very Rare Adverse Effects

May affect up to 1 in 10,000people treated with Retrovir:

A very rare adverse effect that may appear in blood tests is:

• bone marrow failure to produce new blood cells (aplastic anemia).

If you experience any type of adverse effect

• Consult your doctor or pharmacist. This includes any possible adverse effects not mentioned in this prospectus.

Other possible adverse effects of combined HIV treatment

Other conditions may develop during HIV treatment.

Infections may recur

Patients with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop severe infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are likely caused by the immune system reacting to these infections.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you start taking medications for HIV treatment. Autoimmune disorders may appear many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving up to the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

If you have any symptoms of infection during treatment with Retrovir:

• Tell your doctor immediately. Do not take other medications without your doctor's advice.

Lactic acidosis is a rare but serious adverse effect

Some people taking Retrovir develop a condition called lactic acidosis, along with an increase in liver size. Lactic acidosis is due to an increase in lactic acid levels in the body. It is rare and if it occurs, it usually develops after a few months of treatment. It can be potentially life-threatening, causing failure of internal organs.

Lactic acidosis is more likely to develop in patients with some liver condition or in obese people (with significant overweight), especially women.

Signs of lactic acidosis include:

• difficult, rapid, and deep breathing

• drowsiness

• numbnessor weaknessin the limbs
• loss of appetite, weight loss

• discomfort(nausea) and vomiting

• stomach pain.

During treatment, your doctor will monitor any signs that may indicate you are developing lactic acidosis. If you have any of the symptoms mentioned above, or are concerned about any other symptom:

• Go to your doctor as soon as possible.

You may have bone problems

Some patients receiving combined HIV treatment develop a bone disease called osteonecrosis. With this disease, part of the bone tissue dies due to a reduction in blood supply to the bone.

People are more likely to suffer from this disease:

• if they have been taking combined treatment for a long time

• if they also take anti-inflammatory medications called corticosteroids
• if they drink alcohol
• if their immune system is severely weakened
• if they are overweight.

Signs of osteonecrosis include:

• joint stiffness

• pain(especially in the hip, knee, or shoulders)

• difficulty moving.

If you notice any of these symptoms:

• Tell your doctor.

Other effects that may appear in tests

Combined HIV treatment can also cause:

• increased lactic acid levelsin the blood, which can rarely lead to lactic acidosis.

This effect can be seen in blood tests during treatment with Retrovir.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Retrovir

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C. Store in the original packaging.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Retrovir Composition

The active ingredient is zidovudine. Each capsule contains 250 mg of zidovudine.

The other components are: cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose, magnesium stearate, titanium dioxide (E171), gelatin, carmine indigo (E132), and Opacode black 10A1 or 10A2 ink (varnish, black iron oxide (E172), propylene glycol, ammonium hydroxide, 28% (only in Opacode black 10A1), concentrated ammonia solution (only in Opacode black 10A2), potassium hydroxide (only in Opacode black 10A2)).

Product Appearance and Package Contents

Retrovir 250 mg are hard gelatin capsules, white body and blue cap, marked with the code “GSJV2” printed in black ink. They are packaged in blisters and supplied in packages of 40 capsules.

Marketing Authorization Holder

ViiV Healthcare, S.L.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: + 34 900 923 501

[email protected]

Manufacturer

Delpharm Poznan Spólka Akcyjna - ul. Grunwaldzka 189 – (60-322 Poznan) – Poland

Date of the last revision of this prospectus:April 2021.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/