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HARTEZE 10MG TABS 28s

Product code: 1130541

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HARTEZE contains rivaroxaban, a direct factor Xa inhibitor used to prevent and treat blood clots in conditions such as DVT, pulmonary embolism, and atrial fibrillation-related stroke risk. It offers convenient oral anticoagulation without the need for routine blood monitoring.

Ksh 79

3. What Is HARTEZE 10mg and What Is It Used For?

What Is HARTEZE 10mg?

Harteze 10mg contains Rivaroxaban, a direct oral anticoagulant (DOAC) that works by selectively blocking Factor Xa, a key protein in the clotting cascade. By blocking this single step, Rivaroxaban prevents blood clots from forming without the need for regular blood test monitoring required by older anticoagulants like Warfarin.

The 10mg dose is specifically designed for shorter-duration, preventive use, particularly after surgery, making it a convenient, once-daily option for patients at risk of developing dangerous blood clots.

What Is It Used For?

Harteze 10mg is used to prevent blood clots (deep vein thrombosis, DVT, and pulmonary embolism, PE) after major knee or hip replacement surgery, where the risk of clot formation is significantly elevated. It is also used for extended VTE prevention in medical patients at continued risk after hospitalisation, and in some cases for secondary prevention of recurrent blood clots at the lower dose following initial higher-dose treatment.

In Kenya, Harteze 10mg is increasingly prescribed as orthopaedic surgery rates rise, offering patients a simple once-daily tablet instead of daily injections for clot prevention.

 

4. How to Take This Medicine

Usual Dose

10mg once daily, taken with or without food for this indication.

After Hip Replacement

Start 6–10 hours after surgery. Continue for 5 weeks (35 days).

After Knee Replacement

Start 6–10 hours after surgery. Continue for 2 weeks (14 days).

Consistency

Take at the same time every day. Do not miss doses, gaps in anticoagulation create windows of clot risk.

Missed Dose

Take as soon as remembered on the same day. If you miss a full day, do not double up, just continue from the next scheduled dose.

Switching From Injections

Follow your doctor's guidance on timing when switching from injectable anticoagulants.

 

5. Side Effects

Common Side Effects

·       Bleeding, including bruising more easily, longer time to stop bleeding from cuts

·       Nausea

·       Mild dizziness

Uncommon Side Effects

·       Headache

·       Hypotension (low blood pressure)

·       Elevated liver enzymes

Serious Side Effects, Seek Immediate Medical Attention

·       Serious or life-threatening bleeding, internal bleeding in the brain, GI tract, or surgical site (seek emergency care immediately for unusual or heavy bleeding)

·       Anaemia from occult blood loss

·       Severe allergic reactions (rare)

 

6. Contraindications

 

The following patients should NOT use this medication:

• Active clinically significant bleeding

• Lesions or conditions at significant risk of major bleeding (e.g., recent brain surgery, active GI ulcer)

• Severe renal impairment (eGFR < 15 ml/min)

• Severe hepatic impairment with coagulopathy

• Concurrent use of other anticoagulants (without clear medical justification)

• Pregnancy and breastfeeding

• Hypersensitivity to rivaroxaban

 

 

 

7. Safety Warnings and Special Precautions

·       BLEEDING RISK: The most important risk with any anticoagulant. Seek immediate medical attention for unusual, heavy, or prolonged bleeding, especially from the gut (dark/black stools, coughing blood) or head (sudden severe headache, weakness on one side).

·       NO ROUTINE MONITORING NEEDED: Unlike Warfarin, Harteze does not require routine INR blood tests, but kidney function should be monitored periodically.

·       REVERSAL AGENT: Andexanet alfa is the specific reversal agent for Factor Xa inhibitors, though availability in Kenya is limited. Inform all treating doctors and dentists that you are on Harteze.

·       SPINAL PROCEDURES: Epidurals and spinal anaesthesia carry a risk of spinal haematoma when used with anticoagulants, your anaesthetist must know you are on Harteze.

·       SURGERY / DENTAL PROCEDURES: Always inform your surgeon or dentist. Rivaroxaban must be stopped before invasive procedures as directed.

·       MISSED DOSES: Do not double up, a missed dose creates a temporary gap in protection but doubling increases bleeding risk.

 

8. Drug Interactions

Other anticoagulants (warfarin, heparin, DOACs): Avoid concurrent use, additive bleeding risk.

Antiplatelet agents (aspirin, clopidogrel): Significantly increased bleeding risk, use only when clearly necessary.

NSAIDs (ibuprofen, diclofenac): Increased bleeding risk, avoid or use with caution.

Strong CYP3A4 + P-gp inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin): Significantly increase Rivaroxaban levels, avoid.

Strong CYP3A4 + P-gp inducers (rifampicin, phenytoin, carbamazepine): Significantly reduce Rivaroxaban levels, avoid.

St John's Wort: Reduces anticoagulant efficacy.

 

9. Storage Instructions

·       Store below 30°C in a cool, dry place.

·       Keep in original blister packaging.

·       Protect from moisture.

·       Keep out of reach of children.

 

10. Prescription Status in Kenya

Harteze 10mg is a prescription-only medicine (POM) in Kenya. It must be prescribed by a registered physician, haematologist, cardiologist, or orthopaedic surgeon. Available at Pharmily with a valid prescription.

 

11. Patient Guidance

 

💊 Key Points for Patients:

Take Harteze every day at the same time, do not skip doses. Even one missed day can create a window of risk.

Tell every doctor, dentist, or healthcare professional you see that you are taking a blood-thinning medicine.

Watch for unusual bleeding, dark or tarry stools, blood in urine, unexplained bruising, or bleeding that won't stop.

Seek emergency care immediately for any signs of internal bleeding, sudden severe headache, weakness on one side of the body, or coughing up blood.

Avoid taking ibuprofen or aspirin for pain relief, use paracetamol instead. Ask your pharmacist before taking any new medicine.

If you need any procedure, surgery, or dental work, tell the provider about Harteze, it will need to be stopped for a period beforehand.

 

 

 

12. Pharmacist / Prescriber Notes

Harteze 10mg (Rivaroxaban) is the preventive VTE dose, confirm the indication matches the dose strength before dispensing. The 10mg dose is for post-orthopaedic VTE prophylaxis and extended secondary prevention, the 15mg and 20mg doses are for treatment of established DVT/PE and AF stroke prevention.

Counsel explicitly on the strong CYP3A4/P-gp inhibitor interaction, azole antifungals and HIV antiretrovirals (ritonavir) are common in Kenya and are absolute contraindications. Rifampicin (first-line TB treatment in Kenya) dramatically reduces Rivaroxaban levels; alternative anticoagulation is required for TB patients.

Document the bleeding counselling and advise patients to carry an anticoagulant alert card. No INR monitoring needed, but check renal function (eGFR) before and periodically during therapy.

 

13. Frequently Asked Questions (FAQs)

Do I need blood tests to monitor Harteze?

A: Unlike Warfarin, Harteze does not require routine INR blood tests. However, your doctor will check your kidney function periodically, as Rivaroxaban is partly eliminated by the kidneys.

What should I do if I bleed while on Harteze?

A: Minor cuts and bruises are expected, apply pressure and these will usually stop. Seek immediate emergency medical care for heavy, unusual, or internal bleeding, including black or tarry stools, blood in urine, coughing up blood, or sudden severe headache.

Can I take paracetamol for pain while on Harteze?

A: Yes, paracetamol at normal doses is generally safe with Harteze. Avoid ibuprofen, aspirin, and other NSAIDs unless your doctor specifically approves.

What happens if I miss a dose of Harteze?

A: Take the missed dose as soon as you remember on the same day. If you forget for a full day, simply continue with your next scheduled dose. Never take two doses at once.

I am on TB treatment (rifampicin), can I take Harteze?

A: No, rifampicin dramatically reduces Rivaroxaban levels, making it ineffective. Your doctor will need to prescribe a different anticoagulant while you are on TB treatment.


 

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