Lopinavir And Ritonavir Cipla

LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS are indicated in combination with other antiretroviral agents for the treatment of HIV infection.

Do not take LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS if:

• You are allergic to lopinavir, ritonavir or to any of the other ingredients of LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS.
• You have severe liver disease.
• You are currently taking any of the following medicines:
• Sedatives such as midazolam or triazolam (for anxiety or sleeping problems).
• Ergot derivatives, such as ergotamine, dihydroergotamine, and methylergonovine (for the treatment of migraines).
• Antipsychotics, such as pimozide (to treat schizophrenia).
• Gastrointestinal motility agents/stomach complications medicines such as cisapride.
• Sildenafil, (used for pulmonary hypertension).
• Alfuzosin (used for treatment of enlarged prostate).
• Antidysrhythmics, used for heart conditions- abnormal heart rhythms like dronedarone.
• Colchicine, used for treating gout.
• Hypericum perforatum (St. John’s Wort for depression).
• Rifampin, which is used for treating tuberculosis (TB).
• Cholesterol (too much fat in your body) lowering medicines like simvastatin and lovastatin.

Take special care with LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS:

Combination antiretroviral treatment such as LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS is associated with complications that may need medical attention. Consult your doctor if the following problems arise while on LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS treatment:

• Body fat redistribution indicated by central obesity, dorso-cervical fat, enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement.
• You become prone to opportunistic infections including TB, flu, skin and/or eye infections. Fever and generally feeling weak can be a sign of infections.
• Bone death and/or wasting. Your bones may become weakened and painful, this condition may be aggravated by corticosteroid use and alcohol consumption.
• Diabetes mellitus (high blood sugar), signs include unusual thirst and frequent urination.
• Abdominal pain, this can be a sign of liver impairment or impaired function of the pancreas.
• You become prone to bleeding.
• You have a history of or suffer from heart problems like abnormal heart rhythms, this can be life-threatening due to the risk of heart attacks.
• You previously developed resistance to other HIV medicines.
• You have haemophilia type A and B as there may be an increased risk of bleeding.

Do not share medicines prescribed for you with any other person. Always take LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Caregivers, parents or guardians must also give LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS according to the patient’s doctor’s instructions.

REMEMBER TO ALWAYS TAKE LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS WITH FOOD.

Method of administration: Capsules containing the oral pellets should not be swallowed whole but should be administered with food as shown below (capsule contents should be emptied into ready-to-eat-porridge).

• Place sweetened porridge, which is at room temperature, in a small bowl.
• Obtain the prescribed number of capsules needed for a dose.
• Hold both ends of the capsule between your fingertips as depicted above.
• Twist the ends of the capsule in opposite direction and pull apart so that the entire contents of the capsule are sprinkled over the sweetened porridge.
• Repeat this step for the prescribed number of capsules per dose. Ensure that the entire content of each capsule is sprinkled over the porridge.
• This medicine-porridge mixture should be eaten immediately. The oral pellets should not be chewed or crushed. They should not be stored for future use.
• Administration of the required dose should be followed by drinking water, to ensure that no pellets are left behind in the mouth.
• Repeat above steps for next dose.

The recommended dose must be taken twice daily with food. You doctor will determine the correct dose for you.

Not all side effects reported for LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Irregular (too high or slow) heart rates, this might be risk factor for stroke.
• Heart attack.
• Liver disease or liver failure (symptoms include abdominal pain, nausea and vomiting).
• Yellowing of the skin and/or eyes, also known as jaundice.
• Kidney disease, including kidney stones, signs include severe back pain and pain on the sides of your body and groin area and painful and frequent urination.
• Steven-Johnson syndrome, a life-threatening condition indicated by fever, fatigue and development of painful widespread blisters and ulcers on the skin, mouth area, face and limbs.
• Erythema multiforme, life threatening conditions affecting the skin, symptoms include itchy and/or sore, mostly reddish-looking skin rash, fever, feeling weak, eye pain and joint aches.

These are all very serious side effects. If you have them, you may have had a serious reaction to LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Frequent side effects:

• High blood pressure (may be indicated by nosebleeds and shortness of breath).
• Diarrhoea (runny tummy, possibly with nausea and vomiting).
• Any form of infections such as flu-like illness, sore throat, persistent coughs, coughing bloody phlegm, occurrence of boils on your skin, blisters or cold sores in your mouth or groin, urine retention and burning urine (may be a sign of urinary tract infection), ear infection, sneezing and stomach bug. Usually, infections are accompanied by fever and fatigue.
• Diabetes, high blood sugar (excessive thirst, sweating and frequent urination may be a sign of high blood sugar).
• Frequent lightheadedness (also called postural hypotension).

Less frequent side effects:

• Anaemia, you may feel unusually faint and appear pale.
• Blood clots (this condition is asymptomatic but risk factors include tenderness, pain, discolouration and swelling around affected veins).
• Cholecystitis (also known as gall stones, you might experience severe belly pain accompanied by nausea and vomiting).
• Asthma.
• Breathlessness.
• Chest pain.
• Eczema (skin disorder with skin becoming rough and blistered, with bleeding and itchiness).
• Appearance of moles and lumps on the skin.
• Encephalopathy (brain injury/ brain dysfunction, numerous parts of the body are affected by this syndrome, symptoms include loss of cognitive function, inability to concentrate, not being in control of emotions, impaired muscle function/ breathing/ body movements).

These are serious side effects. You may need urgent medical attention.

Store in the original container at or below 30 C. KEEP OUT OF REACH AND SIGHT OF CHILDREN.