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The product code(s) for this leaflet is: PL 20011/0068.
Sinthrome Tablets 1 mg
Sinthrome® 1 mg Tablets
Acenocoumarol
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
1. What Sinthrome is and what it is used for
2. What you need to know before you take Sinthrome
3. How to take Sinthrome
4. Possible side effects
5. How to store Sinthrome
6. Contents of the pack and other information
Sinthrome 1 mg Tablets (acenocoumarol) belongs to a group of medicines called anticoagulants (blood thinning medicines).
Sinthrome is used to treat and prevent blood clots blocking the blood vessels e.g. deep vein thrombosis (DVT).
Sinthrome does not dissolve blood clots that have already formed but it may stop the clots from becoming larger and causing more serious problems.
Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet.
If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Sinthrome.
Talk to your doctor or pharmacist before taking Sinthrome Tablets.
Before you take Sinthrome tell your doctor or pharmacist if you:
You should NOT receive any injections into your muscles whilst you are taking Sinthrome.
If you need any injections into your spine or as part of a scan or X-ray test or if you need minor surgery, including dental surgery, make sure you discuss your treatment with your doctor first.
If you are involved in an accident while on Sinthrome you are likely to bleed more than normal. The doctor or hospital staff must be informed that you are taking Sinthrome immediately. Always carry your personal anticoagulation card (an identification card from your pharmacist stating that you are using this medicine).
Calciphylaxis, a condition in which calcium builds up in blood vessels in the skin, sometimes happens when patients are taking blood thinning medicines including Sinthrome. This is rare, but it causes painful skin lumps or ulcers which can lead to serious infection and death. It usually only happens if a person has serious kidney disease, or if they already have something wrong with the levels of calcium, albumin, phosphate, or certain proteins, in their blood.
If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Sinthrome.
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without prescription (over-the-counter). This applies especially to the following medicines as they may interfere with Sinthrome:
Medicines that increase the activity of Sinthrome such as:
When Sinthrome is prescribed in combination with these drugs, more frequent monitoring (including blood tests) will be needed.
Other medicines that may increase the activity of Sinthrome such as:
Medicines that may decrease the effect of Sinthrome such as:
Medicines that may either increase or decrease the effects of Sinthrome:
Effects of Sinthrome on other medicines
Be careful when drinking alcohol as it may affect how Sinthrome thins your blood. Check with your doctor first.
You should avoid drinking cranberry juice or taking other cranberry products, such as capsules or concentrates as this could mean you do not receive the correct amount of acenocoumarol.
If you are 65 years or older you may be more sensitive to the effects of Sinthrome and so need more frequent check-ups. You may also need lower doses.
Experience with Sinthrome in children and adolescents is limited and so these patients need more frequent check-ups (see Section 3).
Do NOT take Sinthrome if you are pregnant. Sinthrome, like other anticoagulants can cause serious harm to your baby. Tell your doctor if you are pregnant or trying to become pregnant. Your doctor will discuss with you the potential risk of taking Sinthrome during pregnancy.
The decision to breast-feed while taking Sinthrome should be carefully considered with your doctor. You and your child may require blood tests if you are breast-feeding while you are taking Sinthrome. However, as a precaution, your doctor should prescribe vitamin K to your child to prevent their blood from being thinned.
It is not known whether Sinthrome can affect your fertility.
If you are of child bearing age, a pregnancy test may be done by your doctor to rule out pregnancy before you are given Sinthrome. You should use birth control while taking Sinthrome.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Sinthrome has no influence on the ability to drive or use machines. However, you are advised to keep your anticoagulant card with you.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor or pharmacist before taking this medicinal product.
Always take Sinthrome exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.
Sinthrome should be taken as a single dose at the same time every day. Swallow your tablets whole with a drink of water.
Your doctor will arrange regular blood tests during treatment with Sinthrome to check on how fast your blood is clotting. This will help the doctor decide on your dose.
The dose of Sinthrome will vary from patient to patient and from day to day. The following can be used as a guide:
The usual starting dose is between 2 mg/day to 4 mg/day without administration of a loading dose. Treatment can be started with a loading dose regimen, usually 6 mg on the first day followed by 4 mg on the second day.
Elderly patients, patients with liver disease or severe heart failure (which slows blood flow in the liver and may cause its injury) or malnourished patients may need lower doses.
Experience with blood thinning medicines including Sinthrome in children and adolescents is limited. If Sinthrome is used in children or adolescents, blood should be tested more often, to see how well the medicine is working.
Tell your doctor or dentist or pharmacist at every visit that you are using Sinthrome.
If you accidentally take too many tablets, or someone else takes any of your medicine, you should tell your doctor immediately or contact the nearest accident and emergency department. The symptoms of overdose differ between people. They may appear 1 to 5 days after taking the medicine and include nosebleeds, bleeding from the gums, vomiting or coughing blood, blood in the urine, bloody or black tarry stools, genital bleeding, abundant menstrual bleeding, large bruises, or bleeding into the joints which causes tightness, swelling, and pain. Your heartbeat may speed up, your blood pressure may drop making you feel dizzy, and your skin may seem pale, cold and sweaty. You may experience sickness, vomiting, diarrhoea and abdominal pains. You may require blood tests to monitor your condition and treatment may be required. Show any left-over medicines or the empty packet to the doctor.
Do not worry. If you forget to take a dose, take it as soon as possible, unless it is almost time to take the next dose. Do NOT take a double dose. Then go on as before.
If you have any questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Sinthrome can cause side effects, although not everyone gets them.
Tell your doctor straight away if you have any of the following side effects:
Common (may affect up to 1 in 10 people):
Rare (may affect up to 1 in 1000 people):
Very rare (may affect up to 1 in 10,000 people):
Frequency not known: A painful skin rash. Sinthrome can cause a serious rare skin condition called calciphylaxis that can start with a painful skin rash but can lead to serious complications. This adverse reaction occurs most often in patients with chronic kidney disease or something wrong with the levels of calcium, albumin, phosphate, or certain proteins, in their blood. Condition of having a lower-than-normal number of red blood cells or reduced haemoglobin (Anaemia).
If youget 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 the Yellow Card Scheme at: 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.
Keep this medicine out of the sight and reach of children.
Do not take Sinthrome after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
If your doctor decides to stop your treatment, return any unused medicine to the pharmacist. Only keep it if your doctor tells you to.
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.
The active substance is acenocoumarol 1mg. This is the new name for nicoumalone. The ingredient itself has not changed.
The other excipients are: aerosol 200 (silica aerogel), lactose, hypromellose, magnesium stearate, maize starch and talc.
Sinthrome tablets are white, round, flat tablets with slightly bevelled edges, with “CG” imprinted on one side and “AA” on the other. They come in blister packs of 100 tablets.
Marketing Authorisation Holder
Manufacturer
The information in this leaflet applies only to Sinthrome. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.
This leaflet was last revised in October 2022
Sinthrome is a registered trademark of Novartis Pharmaceuticals Limited