Savaysa
(Edoxaban Tosylate)

What Savaysa is and what it is used for

Lixiana contains the active substance edoxaban and belongs to a group of medicines called anticoagulants. This medicine helps to prevent blood clots from forming. It works by blocking the activity of factor Xa, which is an important component of blood clotting. Lixiana is used in adults to:
•prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor.
•treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels in the lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels in the legs and/or lungs.

How to take Savaysa

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. How much to take The recommended dose is one 60 mg tablet once daily.
•If you have impaired kidney function, the dose may be reduced to one 30 mg tablet once daily by your doctor.
•If your body weight is 60 kg or lower, the recommended dose is one 30 mg tablet once daily.
•If your doctor has prescribed medicines known as P-gp inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole, the recommended dose is one 30 mg tablet once daily. How to take the tablet Swallow the tablet, preferably with water. Lixiana can be taken with or without food. Your doctor may change your anticoagulant treatment as follows: Changing from vitamin K antagonists (e.g. warfarin) to Lixiana Stop taking the vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to start taking Lixiana. Changing from non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) to Lixiana Stop taking the previous medicines (e.g. dabigatran, rivaroxaban, or apixaban) and start Lixiana at the time of the next scheduled dose. Changing from parenteral anticoagulants (e.g. heparin) to Lixiana Stop taking the anticoagulant (e.g. heparin) and start Lixiana at the time of the next scheduled anticoagulant dose. Changing from Lixiana to vitamin K antagonists (e.g. warfarin) If you currently take 60 mg Lixiana: Your doctor will tell you to reduce your dose of Lixiana to a 30 mg tablet once daily and to take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to stop taking Lixiana. If you currently take 30 mg (dose reduced) Lixiana: Your doctor will tell you to reduce your dose of Lixiana to a 15 mg tablet once daily and to take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to stop taking Lixiana. Changing from Lixiana to non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) Stop taking Lixiana and start the non-VKA anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled dose of Lixiana. Changing from Lixiana to parenteral anticoagulants (e.g. heparin) Stop taking Lixiana and start the parenteral anticoagulant (e.g. heparin) at the time of the next scheduled dose of Lixiana. Patients undergoing cardioversion: If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take Lixiana at the times your doctor tells you to prevent blood clots in the brain and other blood vessels in your body. If you take more Lixiana than you should Tell your doctor immediately if you have taken too many Lixiana tablets. If you take more Lixiana than recommended, you may have an increased risk of bleeding. If you forget to take Lixiana You should take the tablet immediately and then continue the following day with the once daily tablet as usual. Do not take a double dose on the same day to make up for a forgotten dose. If you stop taking Lixiana Do not stop taking Lixiana without talking to your doctor first, because Lixiana treats and prevents serious conditions. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Like other similar medicines (medicines to reduce blood clotting), Lixiana may cause bleeding which may potentially be life-threatening. In some cases the bleeding may not be obvious. If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately. Your doctor may decide to keep you under closer observation or change your medicine. Overall list of possible side effects:

Common (may affect up to 1 in 10 people):
• Stomach ache
• Abnormal liver blood tests
• Bleeding from the skin or under the skin
• Anaemia (low levels of red blood cells)
• Bleeding from the nose
• Bleeding from the vagina
• Rash
• Bleeding in the bowel
• Bleeding from the mouth and/or throat
• Blood found in your urine
• Bleeding following an injury (puncture)
• Bleeding in the stomach
• Dizziness
• Feeling sick
• Headache
• Itching

Uncommon (may affect up to 1 in 100 people):
• Other types of bleeding
• Bleeding in the eyes
• Bleeding from a surgical wound following an operation
• Blood in the spit when coughing
• Bleeding in the brain
• Reduced number of platelets in your blood (which can affect clotting)
• Allergic reaction
• Hives

Rare (may affect up to 1 in 1,000 people):
• Bleeding in the muscles
• Bleeding in joints
• Bleeding in the abdomen
• Bleeding in the heart
• Bleeding inside the skull
• Bleeding following a surgical procedure

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Ireland HPRA Pharmacovigilance Earlsfort Terrace, IRL – Dublin 2 Tel: +353 1 6764971, Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. Or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine

How to Store Savaysa

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 on each blister after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. 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