Nirmacom Film-Coated Tablets

NIRMACOM contains two medicines packaged together, nirmatrelvir and ritonavir. It belongs to a group of medicines called antivirals. Nirmatrelvir is active against the virus that causes coronavirus disease 2019 (COVID-19). Ritonavir prolongs the therapeutic effect of nirmatrelvir. NIRMACOM is used for treating mild to moderate coronavirus disease 2019 (COVID-19) in adults 18 years of age and older. It is only used in patients who are at high risk for progression to severe COVID-19, including hospitalisation or death. NIRMACOM stops the virus from multiplying in cells and this stops the virus from multiplying in the body. This can help your body to overcome the virus infection and may help you get better faster. You must talk to a health care provider if you do not feel better or if you feel worse while on treatment with NIRMACOM.

Do not take NIRMACOM:

• if you are hypersensitive (allergic) to nirmatrelvir, ritonavir or any of the other ingredients of NIRMACOM (listed in section 6).
• if you have severe liver disease
• if you have severe kidney disease
• If you are taking certain medicines with NIRMACOM because they may lead to serious and/or life-threatening reactions, or may affect how NIRMACOM works. These medicines include, but not limited to:
• Afluzosin, used to treat symptoms of enlarged prostate
• Amiodarone, used to treat heart conditions and correct irregular heartbeats
• Colchicine, used to treat gout
• Pimozide, used to treat mood disorders
• Ergotamine, used to treat migraine
• Simvastatin, used to control cholesterol
• Sildenafil, used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery)
• Pethidine, used for pain
• clonazepam, diazepam, estazolam, flurazepam, triazolam, midazolam taken orally, used to relieve anxiety and/or trouble sleeping
• Cisapride, used to relieve certain stomach problems
• Venetoclax, used to treat cancer
• Phenobarbitone, used to prevent and control seizures
• Fusidic acid, used to treat bacterial infections
• Rifampicin, used to treat tuberculosis
• St. John’s Wort (hypericum perforatum), a herbal product used in depression and anxiety.

These are not the only medicines that may cause serious effects if taken with NIRMACOM. NIRMACOM may increase or decrease the levels of other medicines. Therefore, it is very important to tell your doctor or healthcare provider about all the medicines you are taking because changes in the dose of your other medicines may be required while you are taking NIRMACOM.

Warnings and precautions

Take special care with NIRMACOM: Tell your doctor or health care provider if:

• You have or have had a liver disease. Do not take NIRMACOM if you have a severe liver disease.
• You are taking HIV medicines, as NIRMACOM may result in medicines used in the treatment of HIV to become less effective.

Children and adolescents

NIRMACOM should not be used in children and adolescents under 18 years. NIRMACOM has not been studied in children and adolescents.

Other medicines and NIRMACOM

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your healthcare provider if you are taking combined hormonal contraceptive as NIRMACOM may affect how your birth control pills work. There are other medicines that should not be taken together with NIRMACOM. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not share medicines prescribed for you with any other person. Always take NIRMACOM exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

NIRMACOM consists of 2 medicines: nirmatrelvir and ritonavir. The recommended dose is two tablets of nirmatrelvir with one tablet of ritonavir by mouth twice daily (in the morning and at night). A course of treatment lasts 5 days. For each dose, take all 3 tablets together at the same time. If you have kidney disease, please talk to your healthcare provider for an appropriate dose of NIRMACOM. If you have moderate kidney disease you will need a lower dose of NIRMACOM. If you have severe kidney disease you must not take NIRMACOM. Swallow the tablets whole. Do not chew, break or crush the tablets. NIRMACOM can be taken with or without meals.

If you take more NIRMACOM than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take NIRMACOM

If you forget to take a dose of NIRMACOM, take it as soon as you remember. If more than 8 hours have passed since your missed dose, then do not take the missed dose and just carry on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking NIRMACOM

Even if you feel better, do not stop taking NIRMACOM without talking to your doctor.

NIRMACOM can have side effects. Not all side effects reported for NIRMACOM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking NIRMACOM, please consult your health care provider for advice. Tell your doctor if you notice the following:

Frequent side effects:

• Diarrhoea
• Vomiting
• Altered sense of taste

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 or to the Holder of certificate of registration through the mail: [email protected]. By reporting side effects, you can help provide more information on the safety of NIRMACOM.

Store all medicines out of reach of children.

• Store at or below 30°C
• Do not refrigerate or freeze
• Store in the original package